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Nicotinamide as an Early Alzheimer's Treatment (NEAT)


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 study will test the effects of a high dose of nicotinamide in adults with mild cognitive impairment (MCI) or mild Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years N/A All No
July 12, 2017
June 30, 2020

  • 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

  • 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

In this Phase II trial, participants will be randomized to take 2 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 4 study visits. An additional 12-month treatment and follow-up period is possible, contingent on initial findings.

Name City State Zip Status Primary Contact
University of California, Irvine
Irvine California 92697 Recruiting Beatriz Yanez, R.N
University of California, Los Angeles
Los Angeles California 90095 Recruiting Celine Ossinalde, MA

University of California, Irvine

Name Role Affiliation
Joshua Grill, PhD Principal Investigator Associate Professor of Psychiatry and Human Behavior

Name Phone Email
Joshua Grill, PhD 949-824-5905
Megan Witbracht, PhD 949-824-3249


A Double-Blind-Randomized, Placebo-Controlled Adaptive Design Trial of Nicotinamide in Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease Dementia