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
Sponsor:
Brief Summary:
or niacinamide, taken in high doses, can reduce phosphorylation of tau (the protein that
accumulates in neurofibrillary tangles) in people with Mild Cognitive Impairment or mild
Alzheimer’s disease (AD) dementia.
Criteria
1. Mild Cognitive Impairment (MCI) or dementia due to Alzheimer’s disease (AD)
2. Biomarker criteria:
Cerebral Spinal Fluid (CSF) Amyloid Beta 1-42 (Aβ42) <= 600 pg/mL, or A ratio of total tau to Aβ42 ≥ 0.39. 3. Mini-Mental State Exam (MMSE) ≥ 20 4. Blood laboratories, urinalysis, and electrocardiogram are within normal limits or deemed clinically not significant by the site investigator 5. Stable medications (including approved AD therapies) for at least 4 weeks 6. At least 6 years of education 7. Able to swallow oral tablets 8. Speaks English fluently 9. Available qualified study partner (≥3 times per week in-person communication with the participant) Exclusion Criteria: 1. Active neurological or psychiatric diagnosis other than AD that may affect cognition and/or function. (Obstructive sleep apnea is permitted, if treated.) 2. Inability to undergo lumbar puncture, including use of Coumadin, novel oral anticoagulants, clopidogrel, or dipyridamole. Use of aspirin <= 325mg daily is permitted. 3. Hachinski ischemic scale > 4
4. Magnetic Resonance Imaging (MRI) incompatibility
5. MRI evidence of cortical stroke >1cm, superficial siderosis, or extensive white matter
hyperintensity (Cardiovascular Health Study score 7-8+)
6. Diagnosis of cancer in the previous 5 years (with the exception of basal or squamous
cell carcinoma)
7. Geriatric Depression Scale (GDS) score >6
8. History within the past 5 years of alcohol or substance use disorder
9. Laboratory evidence of a clinically significant abnormality that may interfere with
study assessments
10. Active partial or total malabsorptive disease (e.g., celiac disease)
11. Resides in a skilled nursing facility
12. Participation in a clinical trial of a potential disease-modifying therapy for AD in
previous 6-months (time between last investigational drug administration and baseline
for the current study)
13. Pregnant, lactating or of child bearing potential (that is, women must be 2 years
post-menopausal or surgically sterile to be considered not child bearing potential).
14. Unwillingness to abstain from over-the-counter nicotinamide for the duration of the
trial
Locations
- University of California, Irvine, Irvine, California, United States, 92697
- University of California, Los Angeles, Los Angeles, California, United States, 90095
