Dr. Richard Holub
Dr. Richard Holub is President, Director, and Principal Investigator of the Alzheimer’s Disease Research Center of Albany. For nearly five decades, his clinical and research work has focused on Alzheimer’s disease, memory disorders, and the development of new diagnostic, treatment, and prevention strategies.
Dr. Holub has conducted Alzheimer’s disease clinical trials across phases 1 through 4 and has participated in more than 134 clinical trials. His work has contributed to the clinical development and investigation of medications currently approved by the U.S. Food and Drug Administration for the treatment of Alzheimer’s disease.
Throughout his career, Dr. Holub has worked with individuals and families affected by memory concerns, mild cognitive impairment, Alzheimer’s disease, and related dementias. His approach emphasizes careful cognitive evaluation, clear communication with patients and families, and access to emerging treatment and research opportunities when appropriate.
As Director of the Alzheimer’s Disease Research Center of Albany, Dr. Holub leads an experienced clinical research team that conducts a broad range of Alzheimer’s disease studies, including treatment trials, biomarker and diagnostic studies, and prevention research for individuals with or without symptoms.
The Center’s more than 6,000 square feet of dedicated clinical and research space includes a laboratory, infusion suite, examination rooms, and cognitive-testing rooms. Under Dr. Holub’s direction, the team works closely with local imaging centers, laboratories, and medical specialists to coordinate services needed for cognitive evaluation and clinical research participation.
Since 2017, Dr. Holub and the Alzheimer’s Disease Research Center of Albany have been members of the Global Alzheimer’s Platform Foundation. He shares GAP’s commitment to accelerating Alzheimer’s disease research and expanding access to meaningful study opportunities for patients and families.
Richard F. Holub, M.D.
President, Director and Principal Investigator
Alzheimer’s Disease Research Center of Albany
760 Madison Avenue, Albany, NY 12208
(518) 426-0575 | Fax: (518) 426-1190
| Education: | |
| Rutgers University — Degree: B.A. in Biology New Brunswick, New Jersey |
1965–1969 |
| Georgetown University School of Medicine — Degree: M.D. Washington, DC |
1969–1973 |
| Professional Training: | |
| INTERNSHIP — Internal Medicine Albany Medical Center Hospital, Albany, NY 12208 |
1973–1974 |
| NEUROLOGICAL RESIDENCY Albany Medical Center Hospital, Albany, NY 12208 |
1974–1977 |
| Professional Certifications: | |
| NYS License #120621-1 | 1974 |
| Diplomate, National Board of Medical Examiners | 1974 |
| Diplomate, American Board of Psychiatry and Neurology | 1978 |
Professional Interests:
- Cognitive Neurology
- Alzheimer’s Disease and Memory Disorders Research
- Electroencephalography
- Electromyography
Hospital Appointments:
- Community Staff — Department of Neurology, Albany Medical Center Hospital, Albany, NY
- Community Staff — Department of Neurology, St. Peter’s Hospital, Albany, NY
- Community Staff — Department of Neurology, Albany Memorial Hospital, Albany, NY
Professional Associations:
- Albany County Medical Society
- The Medical Society of the State of New York
- ISTAART
Research Experience & Site Summary:
| Alzheimer’s Disease Research Center of Albany | 1977–Present |
Dr. Holub received his Bachelor of Arts degree from Rutgers University and his Doctor of Medicine degree from Georgetown University School of Medicine. He is a Diplomate of the American Board of Psychiatry and Neurology. In December 2016, he was selected as one of 44 researchers to join the Global Alzheimer’s Platform, a public-private partnership established through a collaboration between the New York Academy of Sciences and the Global CEO Initiative on Alzheimer’s Disease. The partnership brings together leading academic and industry experts from the global Alzheimer’s disease research community.
Dr. Holub served as a member of the St. Peter’s Hospital Institutional Review Board from March 1994 through December 2003 and as Chairman of that IRB from January 1998 through December 2003. In addition, Dr. Holub served as Chairman of the St. Peter’s Hospital Quality Assurance Committee from January 1990 through December 2000.
The Alzheimer’s Disease Research Center of Albany encompasses more than 6,000 square feet of dedicated clinical and research space. The Center has experienced research coordinators, psychometricians, clinical personnel, laboratory personnel, and support staff. Its facilities include a fully functioning laboratory, an infusion suite, examination rooms, and cognitive-testing rooms. The Center also maintains longstanding professional relationships with local imaging centers, laboratories, and medical specialists, allowing it to coordinate the activities required for clinical research studies.
Because the Center’s staff carefully prescreens potential participants, its screen-failure rate is low. The Alzheimer’s Disease Research Center of Albany is recognized for its ability to recruit substantial numbers of eligible participants and maintain strong participant-retention rates.
Clinical Trial Research Experience/Summary:
| “Cell-Mediated Immunity in Multiple Sclerosis” | 1980–1985 |
| “Suloctidil” for the treatment of Alzheimer’s disease | 1985–1988 |
| “HP029” in the treatment of Alzheimer’s disease 201/202/303 | 1988–1994 |
| “Trental” for the treatment of Multi-Infarct Dementia | 1990–1993 |
| “Besipirdine” for the treatment of Alzheimer’s disease | 1993–1994 |
| “Sabeluzole” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 1994–1995 |
| “CI-979” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Phase II | 1994–1996 |
| “Physostigmine” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Double Blind 1025 | 1995–1996 |
| “CI-979” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Phase III | 1995–1997 |
| “Physostigmine” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Open Label 1025B | 1996 |
| “CI-970-68” for the treatment of Alzheimer’s disease | 1996–1999 |
| “E2020-A001-312” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Phase IIIb | 1996–1998 |
| SPECT imaging in probable Alzheimer’s disease patients | 1996 |
| “E2020-A001-314” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Open Label | 1997–1998 |
| “E2020-A001-307” in patients with dementia associated with cerebrovascular disease. STUDY PROTOCOL: Double Blind | 1997–2001 |
| “E2020-A001-309” in patients with dementia associated with cerebrovascular disease. STUDY PROTOCOL: Open Label | 1998–2001 |
| “Galantamine” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Phase III | 1996–1998 |
| “Galantamine” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Open Label | 1997–2001 |
| “Lazabemide” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Phase III, Double Blind | 1997–1998 |
| “Lazabemide” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Open Label | 1998–1999 |
| “Metrifonate” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Phase III | 1997–1998 |
| “Idebenone” for the treatment of Alzheimer’s disease. STUDY PROTOCOL: Phase III | 1997–1999 |
| “MK-0966” for the prevention of Alzheimer’s disease | 1998–1999 |
| “Pregabalin” for the treatment of patients with postherpetic neuralgia pain. STUDY PROTOCOL: Double Blind | 1998–2003 |
| “Pregabalin” for the treatment of patients with diabetic peripheral neuropathy pain. STUDY PROTOCOL: Double Blind | 1998–1999 |
| “Pregabalin” for the treatment of patients with postherpetic neuralgia pain. STUDY PROTOCOL: Open Label | 1998–2001 |
| “Pregabalin” for the treatment of patients with diabetic peripheral neuropathy pain. STUDY PROTOCOL: Open Label | 1998–2001 |
| 00CF clinical trial of the safety and efficacy under a slow-titration regimen of “Galantamine” in the treatment of Alzheimer’s disease. STUDY PROTOCOL: Phase III, Double Blind | 1998–1999 |
| “Galantamine” during withdrawal in the treatment of Alzheimer’s disease | 1999 |
| “Galantamine” in the treatment of Alzheimer’s disease. STUDY PROTOCOL: Open Label | 1999–2001 |
| “Olanzapine vs. Risperidone” and placebo in the treatment of psychosis and associated behavioral disturbances in patients with dementia | 1998–2001 |
| “Ginkgo Biloba Special Extract” in the treatment of patients with Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 1998–2000 |
| “Donepezil” in subjects with mild cognitive impairment. STUDY PROTOCOL: Double Blind | 1999–2001 |
| Cardiac-safety study of “Galantamine” in the treatment of Alzheimer’s disease | 1999 |
| “Donepezil” in the treatment of Alzheimer’s disease withdrawal and rechallenge | 2000–2001 |
| “Buspirone Hydrochloride ER” in the treatment of generalized anxiety disorder. STUDY PROTOCOL: Double Blind | 1999–2001 |
| “Buspirone Hydrochloride ER” in the treatment of generalized anxiety disorder. STUDY PROTOCOL: Open Label | 2001–2002 |
| “MKC-242” in the treatment of major depressive disorder | 1999–2001 |
| “E2020-405” for the treatment of cognitive impairment associated with multiple sclerosis | 2000–2001 |
| “Glatiramer Acetate” orally administered in relapsing and remitting multiple sclerosis patients | 2000–2001 |
| “OPC-14523” in patients with moderate depression | 2000–2001 |
| “CI-1017” in patients with mild to moderate Alzheimer’s disease | 2000–2001 |
| “Pregabalin” in elderly patients with generalized anxiety disorder | 2000–2001 |
| “Aripiprazole” in the treatment of institutionalized patients with psychosis associated with dementia of the Alzheimer’s type | 2000–2001 |
| Controlled-release “Galantamine” in patients with mild to moderate Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 2001–2002 |
| “CP-457,920” in patients with mild to moderate Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 2001–2002 |
| “Galantamine” in patients with mild cognitive impairment. STUDY PROTOCOL: Double Blind | 2001–2003 |
| “FK960” in patients with mild to moderate Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 2001–2002 |
| “Memantine” in patients with moderate to severe dementia of the Alzheimer’s type. STUDY PROTOCOL: Double Blind | 2001–2003 |
| “Memantine” in patients receiving “Donepezil” with moderate to severe Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 2001–2003 |
| “Memantine” in patients with moderate to severe Alzheimer’s disease. STUDY PROTOCOL: Long-Term Extension | 2001–2005 |
| Controlled-release “Galantamine” in patients with mild to moderate Alzheimer’s disease. STUDY PROTOCOL: Open Label | 2001–2003 |
| “FK960” in patients with mild to moderate Alzheimer’s disease. STUDY PROTOCOL: Open Label | 2001–2002 |
| “Galantamine” in patients with dementia secondary to cerebrovascular disease. STUDY PROTOCOL: Double Blind | 2001–2003 |
| “DERA 025” in the treatment of patients with generalized anxiety disorder. STUDY PROTOCOL: Double Blind | 2001–2002 |
| Efficacy and safety of “Atorvastatin 80 mg” plus an acetylcholinesterase inhibitor versus an acetylcholinesterase inhibitor alone over 80 weeks. STUDY PROTOCOL: Double Blind | 2004–2007 |
| STUDY TITLE: A 24-week, multicenter, randomized, double-blind, placebo-controlled evaluation of the efficacy, safety and tolerability of Donepezil Hydrochloride (E2020) in dementia associated with cerebrovascular disease. PROTOCOL NUMBER: E2020-A001-319. SPONSOR: Eisai Medical Research Inc. CRO: PRA | 2002–2005 |
| “Galantamine” in patients with mild cognitive impairment. STUDY PROTOCOL: Open Label | 2003–2005 |
| STUDY TITLE: A 24-week, multicenter, randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of Donepezil Hydrochloride (E2020) in patients with severe Alzheimer’s disease followed by a 12-week open-label extension period. SPONSOR: Eisai, Inc./Pfizer, Inc. CRO: Ingenix | 2002–2005 |
| “Neramexane” in the treatment of mild to moderate Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 2003–2005 |
| “Neramexane” in the treatment of mild to moderate Alzheimer’s disease. STUDY PROTOCOL: Open Label | 2003–2005 |
| “MKC-231” in the treatment of mild to moderate Alzheimer’s disease. STUDY PROTOCOL: Open Label | 2003–2005 |
| STUDY TITLE: An 80-week, randomized, multicenter, parallel-group, double-blind study of the efficacy and safety of Atorvastatin 80 mg plus an acetylcholinesterase inhibitor versus an acetylcholinesterase inhibitor alone in the treatment of mild to moderate Alzheimer’s disease. Protocol Number: A2581078. SPONSOR: Pfizer Inc. CRO: ICON Clinical Research | 2003–2005 |
| Three doses of “NS2330” in the treatment of patients with mild to moderate Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 2003–2005 |
| “Bupropion Hydrochloride” in prevention of seasonal affective disorder. STUDY PROTOCOL: Double Blind | 2003–2005 |
| “L-830982” in the treatment of patients with generalized anxiety disorder. STUDY PROTOCOL: Double Blind | 2002–2003 |
| “Donepezil” in the treatment of patients with mild cognitive impairment. STUDY PROTOCOL: Double Blind | 2003–2006 |
| “Avonex” versus “Betaseron” in the treatment of patients with relapsing-remitting multiple sclerosis | 2003–2005 |
| Four-week, non-interventional study to assess the validity of various assessment scales measuring cognitive and executive function, attention, behavior, and activities of daily living in patients with mild to moderate Parkinson’s disease | 2003–2005 |
| “MK-0677” in slowing the progression of Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 2003–2006 |
| STUDY TITLE: A one-year, multicenter, randomized, double-blind, placebo-controlled evaluation of the safety of Donepezil Hydrochloride (E2020) in subjects with mild cognitive impairment. PROTOCOL NO: E2020-A001-412. SPONSOR: Eisai Inc./Pfizer, Inc. CRO: PRA | 2003–2007 |
| “Xaliproden” in patients with mild to moderate Alzheimer’s disease | 2003–2007 |
| “SB-683699” to investigate MRI efficacy and safety in the treatment of patients with relapsing multiple sclerosis | 2004–2005 |
| Investigation of the safety and efficacy of “Neramexane” in patients with severe Alzheimer’s disease | 2004–2005 |
| Follow-up study with patients previously enrolled in MKC231/01, MKC231/02, MKC231/03 or MKC231/04 | 2004–2005 |
| Safety and tolerability of four doses of “Memantine” in patients with moderate to severe Alzheimer’s disease | 2004–2005 |
| Efficacy, safety and tolerability of “Donepezil Hydrochloride (E2020)” in the treatment of patients with dementia associated with cerebrovascular disease | 2004–2005 |
| Long-term safety and tolerability of “Galantamine HBr” in the treatment of mild cognitive impairment. STUDY PROTOCOL: Open Label | 2004–2005 |
| Clinical trial of “FK962” in patients with mild to moderate Alzheimer’s disease. STUDY PROTOCOL: Phase II, Double Blind | 2004–2006 |
| STUDY TITLE: A Phase III study of the safety and efficacy of ALZHEMED™ in patients with mild to moderate Alzheimer’s disease. PROTOCOL NO: CL-758007. SPONSOR: Neurochem. CRO: Health Decisions | 2004–2006 |
| An analysis of mortality in subjects with mild cognitive impairment who participated in three studies of “Galantamine” | 2004–2005 |
| Clinical trial comparing the efficacy of “Betaseron” 250 mcg subcutaneously every other day with “Avonex” 30 mcg intramuscularly once weekly in relapsing-remitting multiple sclerosis patients | 2004–2005 |
| Clinical trial investigating the safety, tolerability and efficacy of “Betaseron” in relapsing-remitting multiple sclerosis patients | 2005–2006 |
| Clinical trial of “Donepezil Hydrochloride (E2020)” in the treatment of patients with severe Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 2005 |
| Clinical trial of “Donepezil Hydrochloride (E2020)” in the treatment of patients with severe Alzheimer’s disease. STUDY PROTOCOL: Open Label | 2005 |
| Clinical trial of “Donepezil Hydrochloride (E2020)” in the treatment of patients with mild cognitive impairment. STUDY PROTOCOL: Open Label | 2006–2007 |
| Clinical trial of the efficacy and safety of “Alzhemed”™ in mild to moderate Alzheimer’s disease. STUDY PROTOCOL: Open Label | 2006–2008 |
| Clinical trial of the safety, efficacy and tolerability of three doses of “Lecozotan (SRA-333)” in patients with mild to moderate Alzheimer’s disease | 2006–2007 |
| Clinical trial of the safety, efficacy and tolerability of three doses of “Lecozotan (SRA-333)” with a cholinesterase inhibitor in patients with mild to moderate Alzheimer’s disease | 2006–2007 |
| Clinical trial of the long-term efficacy of “Lecozotan (SRA-333)” in patients with mild to moderate Alzheimer’s disease | 2007–2008 |
| Clinical trial of the long-term efficacy of “Lecozotan (SRA-333)” with a cholinesterase inhibitor in patients with mild to moderate Alzheimer’s disease | 2006–2008 |
| Observational study on costs and caregiver burden in Alzheimer’s disease | 2007–2008 |
| Clinical trial to evaluate the effectiveness and safety of “Donepezil Hydrochloride (E2020)” in subjects with mild to severe Alzheimer’s disease residing in an assisted-living facility. STUDY PROTOCOL: Open Label | 2007–2010 |
| Clinical trial of the efficacy and safety of “Bapineuzumab” in patients with mild to moderate Alzheimer’s disease who are apolipoprotein E ε4 non-carriers. STUDY PROTOCOL: Double Blind | 2007–2012 |
| Clinical trial of the efficacy and safety of “Bapineuzumab” in patients with mild to moderate Alzheimer’s disease who are apolipoprotein E ε4 carriers. STUDY PROTOCOL: Double Blind | 2007–2012 |
| Clinical trial of the safety and efficacy of oral “ELND005 (AZD-103)” in Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 2007–2009 |
| Clinical trial evaluating the safety and efficacy of “CG5503 Extended Release” in subjects with painful diabetic peripheral neuropathy | 2007–2009 |
| Clinical trial comparing the combined use of “Interferon Beta-1a” and “Glatiramer Acetate” with either agent alone in patients with relapsing-remitting multiple sclerosis. STUDY PROTOCOL: Double Blind | 2007–2009 |
| Clinical trial to examine the safety and efficacy of “ACP-103” in the treatment of psychosis in Parkinson’s disease. STUDY PROTOCOL: Double Blind | 2008–2009 |
| Clinical study to evaluate the safety and imaging characteristics of “18F-AV-45” in healthy volunteers, patients with mild cognitive impairment, and patients with Alzheimer’s disease. STUDY PROTOCOL: Open Label | 2008–2010 |
| Clinical study to evaluate the comparative efficacy, safety and tolerability of “Exelon 10 and 15 cm² Patch” in patients with Alzheimer’s disease showing decline during an initial open-label treatment phase. STUDY PROTOCOL: Double Blind | 2008–2011 |
| Clinical trial comparison of “23 mg Donepezil Sustained Release” with “10 mg Donepezil Immediate Release” in patients with moderate to severe Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 2008–2011 |
| Clinical trial to evaluate the effect of regularly scheduled neutralizing-antibody testing on treatment patterns versus usual care in high-dose interferon-treated subjects. STUDY PROTOCOL: Open Label | 2008–2010 |
| Clinical trial to investigate the efficacy and safety of “T-817MA” in patients with mild to moderate Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 2008–2010 |
| An extension study of “23 mg Donepezil Sustained Release” in patients with moderate to severe Alzheimer’s disease. STUDY PROTOCOL: Open-Label Extension | 2008–2010 |
| A 26-week, multicenter, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of “PRX-03140” in subjects with Alzheimer’s disease receiving a stable dose of “Donepezil.” STUDY PROTOCOL: Phase II, Double Blind | 2009–2011 |
| A 26-week, multicenter, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of “PRX-03140” as monotherapy in subjects with Alzheimer’s disease. STUDY PROTOCOL: Phase II, Double Blind | 2009–2011 |
| STUDY TITLE: A Phase III study of the correlation between “Florbetapir F 18” (18F-AV-45) PET imaging and amyloid pathology. Protocol Number: 18F-AV-45-A07. SPONSOR: Avid Radiopharmaceuticals, Inc. CRO: In House | 2009–2012 |
| PrecisionMed Sample Registry: Serial Alzheimer’s disease and mild cognitive impairment prospective longitudinal evaluation, including longitudinal cognitive follow-up and serial DNA, RNA, serum, plasma and CSF banking in subjects with mild cognitive impairment or mild Alzheimer’s disease | 2009–2012 |
| A multicenter, randomized, placebo-controlled, parallel-group efficacy and safety trial of “Bapineuzumab” (AAB-001, ELN115727) in patients with mild to moderate Alzheimer’s disease who are apolipoprotein E ε4 carriers. STUDY PROTOCOL: Phase III, Double Blind | 2009–2012 |
| A long-term follow-up study of oral “ELND005 (AZD-103)” in subjects with Alzheimer’s disease | 2009–2012 |
| A multicenter study evaluating patient injection satisfaction with two formulations of “Glatiramer Acetate” for subcutaneous injection utilizing Autoject 2® devices. STUDY PROTOCOL: Open Label | 2010 |
| Longitudinal study of long-term, 36-month cognitive outcomes in healthy volunteers, patients with mild cognitive impairment, and patients with Alzheimer’s disease who had previously undergone PET imaging with “Florbetapir F 18” (18F-AV-45) injection. Protocol Number: 18F-AV-45-A11. Sponsor: Avid Radiopharmaceuticals, Inc. CRO: In House | 2010–2011 |
| Autopsy follow-up of subjects previously imaged with “Florbetapir F 18” (18F-AV-45) PET in trial 18F-AV-45-A07. Sponsor: Avid Radiopharmaceuticals. CRO: In House | 2010–2011 |
| JCV Antibody Program in patients with relapsing multiple sclerosis receiving or considering treatment with “Tysabri”®: STRATIFY-2 | 2010–2013 |
| A multicenter extension trial evaluating the long-term safety and tolerability of “Bapineuzumab” (AAB-001, ELN115727) in subjects with Alzheimer’s disease who participated in Study ELN115727-301 or ELN115727-302. STUDY PROTOCOL: Phase III | 2009–2013 |
| An eight-week, randomized, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of “Agomelatine” 0.5 mg and 1 mg sublingual tablets administered once daily in patients with major depressive disorder. STUDY PROTOCOL: Double Blind | 2011 |
| Long-term, prospective, observational, multinational, parallel-cohort study monitoring safety in patients with multiple sclerosis newly started on “Fingolimod” once daily or treated with another approved disease-modifying therapy. CFTY720D2403. STUDY PROTOCOL: Phase IV, Open Label, Observational | 2011–2014 |
| A 12-month, randomized study comparing the efficacy and safety of “Fingolimod” 0.25 mg and 0.5 mg administered orally with Glatiramer Acetate 20 mg administered subcutaneously once daily in patients with relapsing-remitting multiple sclerosis. Novartis CFTY720D2312. STUDY PROTOCOL: Phase IIIb, Rater and Dose Blinded | 2012–2014 |
| A 12-month, prospective, randomized, active-controlled study evaluating patient retention with “Fingolimod” versus approved first-line disease-modifying therapy in adults in the early stages of treatment for relapsing-remitting multiple sclerosis. Novartis CFTY720DUS09. STUDY PROTOCOL: Phase IV, Open Label | 2012–2014 |
| A Phase II clinical trial evaluating the efficacy and safety of AZD4694 PET in the detection of beta-amyloid in subjects with probable Alzheimer’s disease, older healthy volunteers and young healthy volunteers. STUDY #NAV4-01. SPONSOR: Navidea Biopharmaceuticals. CRO: In House | 2012–2014 |
| STUDY PROTOCOL: TRx-237-015. Sponsor: TauRx. A randomized, double-blind, placebo-controlled, parallel-group, 15-month trial of leuco-methylthioninium bis(hydromethanesulfonate) in subjects with mild to moderate Alzheimer’s disease | 2013–2016 |
| STUDY PROTOCOL: TRx-237-005. Sponsor: TauRx. A randomized, double-blind, placebo-controlled, parallel-group, 18-month safety and efficacy study of leuco-methylthioninium bis(hydromethanesulfonate) in subjects with mild Alzheimer’s disease | 2013–2016 |
| STUDY PROTOCOL: TRx-237-007. Sponsor: TauRx. A randomized, double-blind, placebo-controlled, parallel-group, 12-month safety and efficacy trial of leuco-methylthioninium bis(hydromethanesulfonate) in subjects with behavioral-variant frontotemporal dementia | 2013–2016 |
| STUDY PROTOCOL: NAV4-04. Sponsor: Navidea. Beta-amyloid imaging with 18F-NAV4694 positron-emission tomography in predicting progression to Alzheimer’s disease in subjects with mild cognitive impairment | 2013–2015 |
| Study Protocol: TRx-237-020. Sponsor: TauRx. An open-label extension study of the effects of leuco-methylthioninium bis(hydromethanesulfonate) in subjects with Alzheimer’s disease or behavioral-variant frontotemporal dementia | 2014–2017 |
| Study Protocol: RVT-101-3001. Sponsor: Axovant. A Phase 3, double-blind, randomized study of RVT-101 versus placebo when added to Donepezil treatment in subjects with mild to moderate Alzheimer’s disease | 2015–2017 |
| Study Protocol: 14863A. Sponsor: Lundbeck. Randomized, double-blind, parallel-group, placebo-controlled study of Lu AE58054 in patients with mild to moderate Alzheimer’s disease treated with an acetylcholinesterase inhibitor | 2015–2017 |
| Study Protocol: NEUP11-AD2. Sponsor: Neurim. Randomized, double-blind, parallel-group, placebo-controlled, dose-ranging study of piromelatine in patients with mild dementia due to Alzheimer’s disease | 2015–2016 |
| Study Protocol: NTRP101-202. Sponsor: Neurotrope. A randomized, double-blind, placebo-controlled Phase 2 study assessing the safety, tolerability and efficacy of Bryostatin in the treatment of moderately severe to severe Alzheimer’s disease | 2015–2016 |
| Study Protocol: IDEAS. Sponsor: American College of Radiology. Imaging Dementia—Evidence for Amyloid Scanning Study: a coverage-with-evidence-development longitudinal cohort study | 2016–2018 |
| Study Protocol: TRx-GTD-025. Sponsor: TauRx. Exploratory case-control longitudinal biomarker study in subjects with Alzheimer’s disease or behavioral-variant frontotemporal dementia and untreated matched controls | 2016–2018 |
| Study Protocol: BN29552. Sponsor: F. Hoffmann-La Roche. A Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study of Crenezumab in patients with prodromal-to-mild Alzheimer’s disease | 2016–2019 |
| Study Protocol: RVT-101-3002. Sponsor: Axovant. A long-term, open-label extension study of the safety and tolerability of RVT-101 in subjects with Alzheimer’s disease | 2016–2018 |
| Study Protocol: E2609-G000-302. Sponsor: Eisai, Inc. A placebo-controlled, double-blind, parallel-group, 24-month study evaluating the efficacy and safety of E2609 in subjects with early Alzheimer’s disease | 2017–2020 |
| Study Protocol: NPT088-CL002. Sponsor: Proclara Biosciences, Inc. A Phase 1 randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study of NPT088 in patients with probable Alzheimer’s disease | 2017–2019 |
| Study Protocol: ACP-103-045. Sponsor: ACADIA Pharmaceuticals. A double-blind, placebo-controlled relapse-prevention study of Pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis | 2017–2020 |
| Study Protocol: CTP2S1502HT6. Sponsor: Suven Life Sciences Ltd. A Phase 2a, multicenter, randomized, double-blind, parallel-group, 26-week, placebo-controlled study of 50 mg and 100 mg of SUVN-502 in subjects with moderate Alzheimer’s disease currently treated with Donepezil Hydrochloride and Memantine Hydrochloride | 2017–2020 |
| Study Protocol: E2027-G000-201. Sponsor: Eisai Inc. A placebo-controlled, double-blind, parallel-group, randomized study evaluating the efficacy, safety and tolerability of E2027 in subjects with dementia with Lewy bodies | 2018–2020 |
| Study Protocol: NTRP-101-203. Sponsor: Neurotrope Biosciences. A randomized, double-blind, placebo-controlled Phase 2 study assessing the safety, tolerability and efficacy of Bryostatin in the treatment of moderately severe to severe Alzheimer’s disease subjects not receiving Memantine treatment | 2018–2019 |
| Study Protocol: AGB101-MCD. Sponsor: AgeneBio Inc. A multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of AGB101, low-dose extended-release Levetiracetam, on slowing the progression of mild cognitive impairment due to Alzheimer’s disease | 2018–2022 |
| Study Protocol: BAN2401-G000-301. Sponsor: Eisai, Inc. A placebo-controlled, double-blind, parallel-group, 18-month study with an open-label extension phase to confirm the safety and efficacy of BAN2401 in subjects with early Alzheimer’s disease | 2019–2023 |
| Study Protocol: COR388-010. Sponsor: Cortexyme. A randomized, double-blind, placebo-controlled study of COR388 HCl in subjects with Alzheimer’s disease | 2019–2021 |
| Study Protocol: NTRP101-204. Sponsor: Synaptogenix. A randomized, double-blind, placebo-controlled Phase 2 study assessing the safety, tolerability and long-term efficacy of Bryostatin in the treatment of moderately severe Alzheimer’s disease subjects not receiving Memantine treatment | 2020–2022 |
| Study Protocol: 331-14-213. Sponsor: Otsuka. A Phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled, two-arm, fixed-dose trial evaluating the efficacy, safety and tolerability of Brexpiprazole (OPC-34712) in the treatment of subjects with agitation associated with dementia of the Alzheimer’s type | 2019–2022 |
| Study Protocol: 63733657ALZ2002. Sponsor: Janssen. A randomized, double-blind, placebo-controlled, parallel-group, multicenter study assessing the efficacy and safety of JNJ-63733657, an anti-tau monoclonal antibody, in participants with early Alzheimer’s disease | 2020–2026 |
| Study Protocol: E2027-A001-203. Sponsor: Eisai, Inc. An open-label study evaluating the pharmacodynamic effects, efficacy, safety and tolerability of E2027 in subjects with dementia with Lewy bodies or Parkinson’s disease dementia, with or without amyloid copathology | 2021–2022 |
| Study Protocol: ATH-1017-AD-0201. Sponsor: Athira Pharma. A randomized, placebo-controlled, double-blind study of ATH-1017 treatment in subjects with mild to moderate Alzheimer’s disease | 2020–2024 |
| Study Protocol: ACP-103-046. Sponsor: ACADIA Pharmaceuticals. A Phase 3b, multicenter, randomized, double-blind, placebo-controlled safety study of Pimavanserin therapy in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease | 2020–2021 |
| Study Protocol: ACP-103-047. Sponsor: ACADIA Pharmaceuticals. A 52-week, open-label extension study of Pimavanserin in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease | 2020–2021 |
| A randomized, placebo-controlled, translational study of ATH-1017 in subjects with mild to moderate Alzheimer’s disease | 2021–2024 |
| Assessment of safety, tolerability and efficacy of Donanemab in early symptomatic Alzheimer’s disease | 2021–2025 |
| A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 76-week study evaluating the safety and efficacy of two doses of Simufilam in subjects with mild to moderate Alzheimer’s disease | 2021–2024 |
| A Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety and biomarker effects of ALZ-801 in subjects with early Alzheimer’s disease and APOE4/4 genotype | 2021–2026 |
| Assessment of safety and efficacy measured by amyloid reduction of Remternetug in early symptomatic Alzheimer’s disease | 2022–2025 |
| SEMA4D Blockade Safety and Brain Metabolic Activity in Alzheimer’s Disease: a multicenter, randomized, double-blind, placebo-controlled safety and biomarker study of Pepinemab, an anti-SEMA4D antibody, in early Alzheimer’s disease | 2022–2024 |
| A study of Donanemab versus placebo in participants at risk for cognitive and functional decline of Alzheimer’s disease | 2022–2025 |
| A Phase 3b/4, randomized, double-blind, placebo-controlled, parallel-group study to verify the clinical benefit of Aducanumab (BIIB037) in participants with Alzheimer’s disease | 2022–2024 |
| A randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with Alzheimer’s disease — Hope Study | 2023–2026 |
| A randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy, safety and tolerability of BIIB080 in subjects with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia | 2023–Present |
| A Phase 2/3, double-blind, randomized, placebo-controlled, adaptive-design trial evaluating the efficacy and safety of intravenous ACU193 in early Alzheimer’s disease | 2024–Present |
| A randomized, double-blind, placebo-controlled global study evaluating the efficacy, safety and tolerability of BMS-986446, an anti-MTBR tau monoclonal antibody, in participants with early Alzheimer’s disease — TargetTau-1 | 2024–Present |
| A multicenter, randomized, placebo-controlled, double-blind, parallel-group study assessing the efficacy, safety and immunogenicity of JNJ-64042056, a phosphorylated tau-targeted active immunotherapy, in participants with preclinical Alzheimer’s disease | 2024–Present |
| Development of a database to investigate digital and blood-based biomarkers and their relationship to tau and amyloid PET imaging in older participants who are cognitively normal, have mild cognitive impairment, or have mild-to-moderate Alzheimer’s disease dementia | 2024–2025 |
| A Phase 2b/3, double-blind, placebo-controlled, parallel-group, 36-week, two-arm trial assessing the safety, tolerability and efficacy of Xanamem 10 mg daily in patients with mild or moderate dementia due to Alzheimer’s disease — XANAMIA | 2025–Present |
| A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety of KarXT plus KarX-EC for the treatment of cognitive impairment associated with mild to moderate Alzheimer’s disease — MINDSET 2 | 2025–Present |
| Open-label extension to a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with Alzheimer’s disease — OLE Hope Study | 2024–Present |
| A randomized, double-blind, placebo-controlled study of LHP588 in subjects with P. gingivalis-positive Alzheimer’s disease | 2026–Present |
| A Phase 2, randomized, placebo-controlled, double-blind, parallel-group study evaluating the efficacy and safety of MK-2214 in participants with early Alzheimer’s disease | 2025–Present |
| A Phase 1b, double-blind, placebo-controlled, multiple-ascending-dose study of the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PMN310 in patients with early Alzheimer’s disease | 2025–Present |
Updated as of July 27, 2026