Last updated: September 22, 2023
Sponsor: University of California, Irvine
Overall Status: Completed
Phase
2
Condition
Dementia
Mild Cognitive Impairment
Alzheimer's Disease
Treatment
Placebo Comparator
Nicotinamide
Clinical Study ID
NCT03061474
20163246
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Mild Cognitive Impairment (MCI) or dementia due to Alzheimer's disease (AD)
- Biomarker criteria: Cerebral Spinal Fluid (CSF) Amyloid Beta 1-42 (Aβ42) <= 600 pg/mL, or A ratio of totaltau to Aβ42 ≥ 0.39.
- Mini-Mental State Exam (MMSE) ≥ 20
- Blood laboratories, urinalysis, and electrocardiogram are within normal limits ordeemed clinically not significant by the site investigator
- Stable medications (including approved AD therapies) for at least 4 weeks
- At least 6 years of education
- Able to swallow oral tablets
- Speaks English fluently
- Available qualified study partner (≥3 times per week in-person communication with theparticipant)
Exclusion
Exclusion Criteria:
- Active neurological or psychiatric diagnosis other than AD that may affect cognitionand/or function. (Obstructive sleep apnea is permitted, if treated.)
- Inability to undergo lumbar puncture, including use of Coumadin, novel oralanticoagulants, clopidogrel, or dipyridamole. Use of aspirin <= 325mg daily ispermitted.
- Hachinski ischemic scale > 4
- Magnetic Resonance Imaging (MRI) incompatibility
- MRI evidence of cortical stroke >1cm, superficial siderosis, or extensive white matterhyperintensity (Cardiovascular Health Study score 7-8+)
- Diagnosis of cancer in the previous 5 years (with the exception of basal or squamouscell carcinoma)
- Geriatric Depression Scale (GDS) score >6
- History within the past 5 years of alcohol or substance use disorder
- Laboratory evidence of a clinically significant abnormality that may interfere withstudy assessments
- Active partial or total malabsorptive disease (e.g., celiac disease)
- Resides in a skilled nursing facility
- Participation in a clinical trial of a potential disease-modifying therapy for AD inprevious 6-months (time between last investigational drug administration and baselinefor the current study)
- Pregnant, lactating or of child bearing potential (that is, women must be 2 yearspost-menopausal or surgically sterile to be considered not child bearing potential).
- Unwillingness to abstain from over-the-counter nicotinamide for the duration of thetrial
Study Design
Total Participants: 46
Treatment Group(s): 2
Primary Treatment: Placebo Comparator
Phase: 2
Study Start date:
July 12, 2017
Estimated Completion Date:
August 30, 2022
Study Description
Connect with a study center
University of California, Irvine
Irvine, California 92697
United StatesSite Not Available
University of California, Los Angeles
Los Angeles, California 90095
United StatesSite Not Available
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