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Nicotinamide as an Early Alzheimer's Treatment (NEAT)

Start: July 12, 2017
End: July 30, 2022
Enrollment: 48

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?

Minimum Age: 50 Years

Maximum Age: N/A

Must have:

  • 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
 
Study Contact
Joshua Grill, PhD
Megan Witbracht, PhD

Need Help?

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?

California
University of California, Irvine
Irvine, CA 92697
Recruiting
Beatriz Yanez, R.N
University of California, Los Angeles
Los Angeles, CA 90095
Completed

Who Sponsors This Study?

Lead: University of California, Irvine

Source: ClinicalTrials.gov ID: NCT03061474