Safety Study of Nicotinamide to Treat Alzheimer's Disease

NCT ID: NCT00580931

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2014-07-31

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.

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Subjects will receive experimental drug in a blinded fashion.

Group Type: EXPERIMENTAL

Nicotinamide

Intervention Type: DRUG

1500 mg twice a day for 6 months

2

Identical in size, shape and color to experimental drug.

Group Type: PLACEBO_COMPARATOR

Enduramide placebo

Intervention Type: DRUG

1 tab twice a day

Interventions

Nicotinamide

1500 mg twice a day for 6 months

Intervention Type: DRUG

Enduramide placebo

1 tab twice a day

Intervention Type: DRUG

Other Intervention Names

Enduramide

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alzheimer's Association

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Steven Schreiber

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven S Schreiber, MD

Role: PRINCIPAL_INVESTIGATOR

Regents of the University of California

Locations

UC Irvine School of Medicine

Irvine, California, United States

Countries

United States

Other Identifiers

IIRG-07-61197

Identifier Type: -

Identifier Source: org_study_id