Research Phone: (518) 426-0575 • Clinic Phone: (518) 449-2662 Alzheimersresearch@neurologicalassociatesofalbany.com

About Dr. Holub

Dr. Richard Holub is President and Director, Research & Neurology at Alzheimer’s Disease Research and Treatment Center at Neurological Associates of Albany (NAA). NAA consists of a credentialed research team and clinic staff of nurses, research coordinators, physicians, physician assistants and psychometricians. NAA provides a full complement of Alzheimer’s disease Research programs and neurological services for memory disorders.

 

NAA currently has a panel of over 5,000 patients and provides comprehensive neurological services to over 2,500 patients diagnosed with Alzheimer’s disease, MCI, or other forms of dementia.

 

In addition to providing high quality clinical trials & neurological care, Dr. Holub has been conducting phase II and Phase III clinical trials for over 30 years. During his impressive career, Dr. Holub has conducted over 125 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.

 

NAA’s Research Division encompasses over 3,000 square feet of space and is comprised of experienced certified research coordinators, two psychomatricians, nurses, physician’s assistants, neurologists and a primary care physician. The office has a fully functioning lab, an infusion suite, exam rooms and testing rooms. NAA 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 NAA 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
Clinical and Research Divisions
Neurological Associates of Albany, P.C.
760 Madison Avenue, Albany, N.Y. 12208
(518) 426-0575 | F. (518) 426-1190

e-mail: rholub@naaresearch.com

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:

  • Clinical 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

Neurological Associates of Albany, PC: 1977- Present

 

Dr. Richard Holub is President of Neurological Associates of Albany, PC (NAA) an organization that consists of a highly respected clinic providing a full complement of neurological services and a well-established research center. The clinical arm of NAA currently has a panel of over 4,500 patients and provides comprehensive neurological services to over 1,000 patients diagnosed with Alzheimer’s disease, MCI or other forms of dementia.

 

In addition to providing high quality neurological care, Dr. Holub is also the principal investigator for the Research Division of NAA, where he has been conducting Phase I, Phase II and Phase III clinical trials for over 30 years. During his career, Dr. Holub has conducted over 125 successful clinical trials, has played a significant role in the investigation of all five drugs approved by the FDA for the treatment of Alzheimer’s disease, as well as the first Alzheimer’s disease imaging agent, Florbetapir. In addition to the work Dr. Holub has done in the areas of Dementia and Alzheimer’s disease, he has also been involved in clinical trials investigating treatments for Major Depression, Generalized Anxiety Disorder, Multiple Sclerosis, and painful Diabetic Neuropathy among others.

 

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.

 

NAA’s Research Division encompasses over 3,000 square feet of space and houses four experienced research coordinators, two psychometricians, one of whom is a blinded, board certified Neurologist, a physician’s 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 NAA staff prescreens every patient, the division’s screen failure rate is very low. NAA 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 1/31/19