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Nicotinamide as an Early Alzheimer's Treatment (NEAT)

Start: July 12, 2017
End: August 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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

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?

Who Sponsors This Study?

Lead: University of California, Irvine

Source: ClinicalTrials.gov ID: NCT03061474