Safety Study of Nicotinamide to Treat Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

Efficacy of Nicotinamide for the Treatment of Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580931
• Other study ID #: IIRG-07-61197
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 24, 2007
• Last updated: January 23, 2017
• Start date: January 2008
• Est. completion date: July 2014

Study information

• Verified date: January 2017
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Nicotinamide
1500 mg twice a day for 6 months
• Enduramide placebo
1 tab twice a day

Locations

Country	Name	City	State
United States	UC Irvine School of Medicine	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Alzheimer's Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale-Cognitive Subscale		Baseline, 6 wk, 12 wk, 18 wk, 24 wk