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|
- 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.
University of California, Irvine
Beatriz Yanez, R.N
University of California, Los Angeles
Celine Ossinalde, MA
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
- Green KN, Steffan JS, Martinez-Coria H, Sun X, Schreiber SS, Thompson LM, LaFerla FM. Nicotinamide restores cognition in Alzheimer's disease transgenic mice via a mechanism involving sirtuin inhibition and selective reduction of Thr231-phosphotau. J Neurosci. 2008 Nov 5;28(45):11500-10. doi: 10.1523/JNEUROSCI.3203-08.2008.
- Liu D, Pitta M, Jiang H, Lee JH, Zhang G, Chen X, Kawamoto EM, Mattson MP. Nicotinamide forestalls pathology and cognitive decline in Alzheimer mice: evidence for improved neuronal bioenergetics and autophagy procession. Neurobiol Aging. 2013 Jun;34(6):1564-80. doi: 10.1016/j.neurobiolaging.2012.11.020. Epub 2012 Dec 25. Erratum in: Neurobiol Aging. 2013 Sep;34(9):e3.