Safety Study of Nicotinamide to Treat Alzheimer's Disease

Sponsor

University of California, Irvine (Other)

Overall Status

Completed

CT.gov ID

NCT00580931

Collaborator

Alzheimer's Association (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether nicotinamide, or vitamin B3, is safe and effective in the treatment of Alzheimer's disease.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: Nicotinamide Drug: Enduramide placebo	Phase 1/Phase 2

Detailed Description

The goal of this proposal is to show that, nicotinamide (NA), a B3 vitamin, is safe and effective for the treatment of patients with mild to moderate Alzheimer's disease (AD). NA is known to block the ability of certain proteins to regulate other proteins by removing their acetyl groups. Recent evidence has demonstrated that inhibitors such as NA prevent nerve cell degeneration in models of Huntington's disease (HD), Parkinson's disease and Lou Gehrig's disease (or ALS). Despite these beneficial effects in many different animal models, there have been no studies to date using these inhibitors in AD. In some of our recent studies we found that the potent inhibitor, NA, significantly improves learning and memory in transgenic mice that develop AD. NA treatment also resulted in striking changes in tau, a protein that abnormally accumulates in AD. NA has been extensively used in clinical studies over the last 40 years and is generally safe and well-tolerated. As NA is a safe and readily available vitamin supplement, our recent results provide a strong argument for a study of NA in patients with AD. We therefore propose to treat 50 patients with mild to moderate AD with either NA (1500 milligrams twice a day) or an identical but inactive drug (placebo) for 24 weeks. At 6 week intervals we will assess functions such as learning and memory, and ability to carry out daily activities as well as caregiver reports using standardized tests. We will also perform spinal taps at the beginning and end of the study to measure the level of abnormal tau protein in the cerebrospinal fluid. Blood tests will periodically be done to assess liver function and complete blood counts. The results of this study may provide the basis for a more extensive study of NA for the treatment of mild to moderate AD.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Nicotinamide for the Treatment of Alzheimer's Disease

Actual Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Subjects will receive experimental drug in a blinded fashion.	Drug: Nicotinamide 1500 mg twice a day for 6 months Other Names: Enduramide
Placebo Comparator: 2 Identical in size, shape and color to experimental drug.	Drug: Enduramide placebo 1 tab twice a day

Arm

Intervention/Treatment

Experimental: 1

Subjects will receive experimental drug in a blinded fashion.

Drug: Nicotinamide

1500 mg twice a day for 6 months

Other Names:

Enduramide

Placebo Comparator: 2

Identical in size, shape and color to experimental drug.

Drug: Enduramide placebo

1 tab twice a day

Outcome Measures

Primary Outcome Measures

Alzheimer's Disease Assessment Scale-Cognitive Subscale [Baseline, 6 wk, 12 wk, 18 wk, 24 wk]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of probable AD according to DSM-IV criteria
Mild to moderate dementia based on Mini-Mental State Examination [MMSE] score between 13-25
Minimum age 50 years
Brain imaging (computed tomographic scan or magnetic resonance image) within 12 months consistent with a diagnosis of probable AD
Hachinski Ischemic Score of <4.
Stable doses of concomitant medications, including cholinesterase inhibitors (ChEIs) and/or memantine.

Exclusion Criteria:

Dementia due to another cause
Other neurological or psychiatric diseases
Pseudodementia
Unstable medical condition
Initial treatment within 30 days of screening with a ChEI, memantine or any investigational drug
History of alcoholism, drug abuse, liver disease, peptic ulcer disease
Pregnancy, or the potential to become pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Irvine School of Medicine	Irvine	California	United States	92697

Sponsors and Collaborators

University of California, Irvine
Alzheimer's Association

Investigators

Principal Investigator: Steven S Schreiber, MD, Regents of the University of California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Steven Schreiber, Professor of Neurology, University of California, Irvine

ClinicalTrials.gov Identifier:

NCT00580931

Other Study ID Numbers:

IIRG-07-61197

First Posted:

Dec 27, 2007

Last Update Posted:

Jan 25, 2017

Last Verified:

Jan 1, 2017

Keywords provided by Steven Schreiber, Professor of Neurology, University of California, Irvine

nutraceutical, dementia, cognition, HDAC inhibitor

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2017