Dr. Richard Holub is President and Director, Alzheimer’s Research Center. Alzheimer’s Research Center consists of a credentialed research team and clinic staff of nurses, research coordinators, physicians, a physician assistant and psychometricians. Alzheimer’s Research Center provides a full complement of Alzheimer’s disease Research programs for patients with memory disorders.
Dr. Holub has been conducting phase II and Phase III clinical trials for over 35 years. Dr. Holub has conducted over 134 successful clinical trials and has played a significant role in the investigation of all five drugs currently approved by the FDA for the Treatment of Alzheimer’s Disease.
Alzheimer’s Research Center encompasses over 6,000 square feet of space and is comprised of experienced certified research coordinators, two psychometricians, nurses and a physician assistant. The office has a fully functioning lab, an infusion suite, exam rooms and testing rooms. Alzheimer’s Research Center also has long standing professional relationships with a number of local imaging centers and other specialists allowing for coordination of care and referrals when they are needed.
Dr. Holub and his organization has been appointed as full members of the Global Alzheimer’s disease Foundation Platform (GAP) in 2017. GAP and Alzheimer’s Research Center share the common goal of finding a cure for Alzheimer’s Disease in our lifetime.
Richard F. Holub, M.D., President, Director and Principal Investigator
Alzheimer’s Research Center
760 Madison Avenue, Albany, N.Y. 12208
(518) 426-0575 | F. (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, D.C. |
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 |
| Diplomat, National Board of Medical Examiners | 1974 |
| Diplomat, American Board of Psychiatry and Neurology | 1978 |
Professional Interests:
- Cognitive Neurology
- Alzheimer’s disease and Memory Disorders Research
- Electroencephalography
- Electromyography
Hospital Appointments:
- Consultant – Department of Neurology, Albany Medical Center Hospital, Albany, NY
- Attending – Department of Neurology, St. Peter’s Hospital, Albany, NY
- Consulting Physician – Department of Neurology, Albany Memorial Hospital, Albany, NY
Professional Association:
- Albany County Medical Society
- The New York State Medical Society
- ISTAART
Research Experience & Site summary
| Alzheimer’s Research Center | 1977- Present |
Dr. Holub received his Bachelor of Arts from Rutgers University and his Medical Doctorate from Georgetown University School of Medicine. He is a Diplomat of the American Board of Psychiatry and Neurology. In December 2016, he was selected as one of 44 researchers for membership in the Global Alzheimer’s Platform (GAP), a public-private partnership launched through a collaboration between the New York Academy of Sciences (NYAS) and the Global CEO Initiative (CEOi) on Alzheimer’s disease and engaging the foremost academic and industry thought leaders within the global Alzheimer community.
Dr. Holub served as a member of St. Peter’s Hospital Institutional Review Board (IRB) from March, 1994 through December, 2003 and as Chairman of that IRB from January, 1998 through December, 2003. In addition, Dr. Holub was Chairman of the St. Peter’s Hospital Quality Assurance Committee from January, 1990 through December, 2000.
Alzheimer’s Research Center encompasses over 6,000 square feet of space and houses four experienced research coordinators, two psychometricians, one of whom is a blinded, board certified Neurologist, a physician assistant, as well as lab and support personnel. The office has a fully functioning lab, an infusion suite, three exam rooms and two testing rooms. NAA also has long standing professional relationships with a number of local imaging centers which allows it to conduct all of the activities that are a typical part of any standard clinical trial.
Since Alzheimer’s Research Center staff prescreens every patient, the division’s screen failure rate is very low. Alzheimer’s Research Center is noted for our ability to recruit high numbers of eligible patients and associated high 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 | 1996-1996 |
| “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. | 1996-1996 |
| “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 Post Herpetic 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 Post Herpetic 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 | 1999-1999 |
| “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 |
| “Galantamine” in the treatment of Alzheimer’s disease Cardiac safety study | 1999-1999 |
| “Donepezil” in the treatment of Alzheimer’s disease withdrawal and Re-Challenge | 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” treatment of Cognitive Impairment 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 on “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 treatment of patients with Generalized Anxiety Disorder
STUDY PROTOCOL: Double Blind |
2001-2002 |
| Efficacy and Safety of “Atorvastatin 80 mg” plus Acetyl Cholinesterase Inhibitor vs. Acetyl Cholinesterase Inhibitor Only – 80 Weeks
STUDY PROTOCOL: Double Blind |
2004-2007 |
| STUDY TITLE: A 24-Week, Multi-Center, 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 Protocol Number: E2020-A001-319 SPONSOR: Eisai Medical Research Inc. |
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& EFFICACY OF DONEPEZIL HYDROCHLORIDE (E2020) IN PATIENTS WITH SEVERE ALZHEIMER’S DISEASE FOLLOWED BY 12 WEEK OPEN-LABEL EXTENSION PERIOD. PROTOCOL NUMBER: E2020-A001-3. SPONSOR: Eisai, Inc./Pfizer, Inc. CRO: Ingenix | 2002-2005 |
| “Neramexane” in treatment of Mild to Moderate Alzheimer’s disease
STUDY PROTOCOL: Double Blind |
2003-2005 |
| “Neramexane” in treatment of Mild to Moderate Alzheimer’s disease STUDY PROTOCOL: Open Label. | 2003-2005 |
| “MKC-231” in treatment of Mild to Moderate Alzheimer’s disease STUDY PROTOCOL: Open Label | 2003-2005 |
| STUDY TITLE: An 80 Week, Randomized, Multi-center, Parallel-Group, Double-Blind Study of the Efficacy and Safety of Atorvastatin 80mg Plus Acetylcholinesterase Inhibitor Versus an Acetylcholinesterase. Inhibitor Alone in the Treatment of Mild to Moderate Alzheimer’ disease.
Protocol Number: A2581078. SPONSOR: Pfizer Inc.CRO: ICON CLINICAL RESEARCH |
2003-2005 |
| “Three doses of “NS2330” in 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 treatment of patients with Generalized Anxiety Disorder STUDY PROTOCOL: Double Blind. | 2002-2003 |
| “Donepezil” in treatment of patients with Mild Cognitive Impairment STUDY PROTOCOL: Double Blind | 2003-2006 |
| “Avonex” Versus “Betaseron” in the treatment of patients with Relapsing and Remitting Multiple Sclerosis | 2003-2005 |
| Four-Week, Non-Intervention 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 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, PLACE-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 treatment of patients with Relapsing Multiple Sclerosis | 2004-2005 |
| ” investigating 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 Dosing “Memantine” in patients with Moderate to Severe Alzheimer’s disease | 2004-2005 |
| “Efficacy, safety and tolerability of “Donepezil Hydrochloride (E2020)” in 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 |
| J 1Clinical Trial of “FK962” in patients with Mild to Moderate Alzheimer’s disease. STUDY PROTOCOL: Phase II, Double Blind | 2004-2006 |
|
STUDY TITLE: A Phase 111 Study 0f the Safety and Efficacy of ALZHEMED TM 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 MCI who in 3 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 treatment of patients with severe Alzheimer’s disease. STUDY PROTOCOL: Double Blind | 2005-2005 |
| Clinical Trial of “Donepezil Hydrochloride (E2020)” in treatment of patients with severe Alzheimer’s disease. STUDY PROTOCOL: Open Label | 2005-2005 |
| Clinical Trial of “Donepezil Hydrochloride (E2020)” in treatment of patients with Mild Cognitive Impairment STUDY PROTOCOL: Open Label | 2006-2007 |
| Clinical Trial of the efficacy and safety of “Alzhemed” TM in Mild to Moderate Alzheimer’s disease STUDY PROTOCOL: Open Label | 2006-2008 |
| Clinical Trial of the safety, efficacy and tolerability of 3 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 3 Doses of “Lecozotan (SRA-333)” and Cholinesterase Inhibitor in patients with Mild to Moderate Alzheimer’s Disease | 2006-2007 |
| Clinical Trial of 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)” and 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 Eε4 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 Eε4 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 (ER)” in subjects with painful Diabetic Peripheral Neuropathy | 2007-2009 |
| Clinical Trial comparing the combined use of “Interferon Beta-la” and” Glatiramer Acetate” to 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 “Exelon10 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” to “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-817MAa” 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 111 Study of the Correlation between “Florpiramine F 18” (18F-AV-45) PET Imaging and Amyloid Pathology Protocol Number:18 F-AV-45-A07 SPONSOR: Avid Radiopharmaceuticals, Inc.
CRO: IN HOUSE |
2009-2012 |
| PrecisionMed-Sample Registry: Serial Alzheimer’s disease and MCI Prospective Longitudinal Evaluation. Longitudinal cognition follow-up and serial DNA/RNA/SERUM/PLAZMA/CFS Banking in subjects with MCI 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” (GA) for subcutaneous injection utilizing Autoject2® Devices.
STUDY PROTOCOL: Open Label |
2010-2010 |
| STUDY TITLE; Longitudinal study of long-term (36 month) cognitive outcomes in healthy volunteers, patients with mild cognitive impairment (MCI) and patients with Alzheimer’s disease (AD) who have previously had 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 multicentered extension trial, evaluating the long term safety and tolerability treatment of “Bapineuzumab” (AAB-001 , ELN115727) in subjects with Alzheimer’s disease who participated in Study ELN115727-301 or in study ELN115727-302
STUDY PROTOCOL: Phase III, Double Blind |
2009-2013 |
| An 8-week, randomized, placebo-controlled, parallel-group, multi-center 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 (MDD) STUDY PROTOCOL: Double Blind | 2011-2011 |
| Long term, prospective, observational multinational parallel-cohort study monitoring safety in patients with Multiple Sclerosis (MS) newly started with “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 to compare the efficacy and safety of “Fingolimod” 0.25mg and 0.5mg administered orally with Glatiramer acetate 20mg administered subcutaneously once daily in patients with Relapsing & Remitting Multiple Sclerosis. Novartis CFTY720D2312
STUDY PROTOCOL: Phase IIIb, Rater and Dose Blinded |
2012-2014 |
| STUDY TITLE: A 12-month, Prospective, Randomized, active controlled study to evaluate the patient retention of “Fingolimod” vs. approved first line DMT in adults who are in early stages of treatment for Relapsing & remitting Multiple Sclerosis. Novartis CFTY720DUS09
STUDY PROTOCOL: Phase IV, Open Label |
2012-2014 |
| STUDY TITLE: A Phase 11 Clinical Trial to Evaluate 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-methylthionium 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-methylthionium bis (hydromethanesulfonate) in subjects with Mild Alzheimer’s disease. TauRx | 2013-2016 |
| STUDY PROTOCOL: TRx-237-007. Sponsor: TauRx. A randomized, double blind placebo controlled, parallel-group, 12-month safety& efficacy trial of Leuco-methylthionium bis (hydromethanesulfonate)with behavioral variant frontotemporal dementia (bvFTD). TauRx TRx-237-007 | 2013- 2016 |
| STUDY PROTOCOL: NAV4-04. Sponsor: Navidea
Beta Amyloid Imaging with 18F NAV4694 Positron Emission Tomography (PET) in predicting progression to Alzheimer’s Disease (AD) in subjects with Mild Cognitive Impairment (MCI) |
2013- |
| 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-101versus 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-moderate Alzheimer’s disease treated with an acetylcholinesterase inhibitor; Study 3 |
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 (IDEAS) Study: a Coverage with Evidence Development Longitudinal Cohort Study |
2016- 2018 |
| Study Protocol: TRx-GTD-025. Sponsor: TauRx
Exploratory Case-Controlled, 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-LaRoche
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- |
| 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 to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer’s disease |
2017- |
| 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- |
| 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- |
| 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- |
| Study Protocol: E2027-G000-201 Sponsor: Eisai Inc.
A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study to Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects with Dementia With Lewy Bodies |
2018- |
| Study Protocol: NTRP-101-203 Sponsor: Neurotrope Biosciences
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Assessing the Safety, Tolerability, and Efficacy in Bryostatin in the treatment of moderately Severe to Severe Alzheimer’s Disease Subjects Not Receiving Memantine Treatment |
2018- |
| Study Protocol: AGB101-MCD Sponsor: AgeneBio Inc.
A multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of AGB101 (low-dose Levetiracetam, 220mg, extended release tablet) on slowing progression of mild cognitive impairment due to Alzheimer’s disease |
2018- |
Updated as of 9/28/22
