Safety Study of Nicotinamide to Treat Alzheimer's Disease

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Irvine
• Collaborator: Alzheimer's Association
• Treatments: Niacin; Niacinamide; Nicotinic Acids

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.