Start: July 12, 2017
End: July 30, 2022
What Is This Study About?
Nicotinamide, or niacinamide, is a form of vitamin B3 that researchers are exploring for its possible use in reducing tau, a protein that accumulates in tangles in the brain's of people with Alzheimer's disease. This Phase 2 trial will test the effects of a high dose of nicotinamide in adults with mild cognitive impairment (MCI) or mild Alzheimer's disease. Participants will be randomly assigned to take two tablets daily of either nicotinamide or a placebo pill for 48 weeks. Researchers will measure changes in tau levels in cerebrospinal fluid. The study includes four study visits. An additional 12-month treatment and follow-up period is possible, contingent on initial findings.
Do I Qualify To Participate in This Study?
- MCI or Alzheimer's disease
- Meets biomarker criteria as outlined by the study
- Mini-Mental State Examination score of 20 or higher
- Blood laboratories, urinalysis, and electrocardiogram within normal limits or deemed clinically not significant
- Stable medications (including approved Alzheimer's drugs) for at least 4 weeks
- At least 6 years of education
- Able to swallow oral tablets
- Fluent in English
- Study partner with in-person contact three or more times per week
Must NOT have:
- Neurological or psychiatric diagnosis other than Alzheimer's that may affect cognition and/or function
- Inability to undergo lumbar puncture, including use of warfarin (Coumadin, Jantoven), novel oral anticoagulants, clopidogrel (Plavix), or dipyridamole (Permole, Persantine). Use of 325mg or less of aspirin daily is permitted.
- Inability to undergo magnetic resonance imaging (MRI)
- MRI evidence of cortical stroke greater than 1 cm, or certain deposits or lesions
- Hachinski Ischemic Score of 4 or higher
- Diagnosis of cancer in past 5 years (except basal or squamous cell carcinoma)
- Geriatric Depression Scale score of 6 or higher
- Alcohol or substance use disorder in past 5 years
- Active malabsorptive disorder, such as celiac disease
- Residence in a skilled nursing facility
- Participation in a clinical trial of a potential Alzheimer's disease-modifying therapy in past 6 months
- Pregnant, lactating, or of childbearing potential
- Unwillingness to abstain from over-the-counter nicotinamide
Joshua Grill, PhD
Megan Witbracht, PhD
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
University of California, Irvine
Irvine, CA 92697
Beatriz Yanez, R.N
University of California, Los Angeles
Los Angeles, CA 90095
Lead: University of California, Irvine
Source: ClinicalTrials.gov ID: NCT03061474