Nicotinamide as an Early Alzheimer's Disease Treatment



Status:Recruiting
Conditions:Alzheimer Disease, Cognitive Studies
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:50 - Any
Updated:2/27/2019
Start Date:July 12, 2017
End Date:June 30, 2020
Contact:Joshua Grill, Ph.D.
Email:jgrill@uci.edu
Phone:949-824-5905

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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

The purpose of this research study is to test whether nicotinamide, also known as vitamin B3
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.

Nicotinamide, the amide of nicotinic acid (vitamin B3/niacin), is an oral therapy with a
wealth of clinical data in a variety of therapeutic areas, including preliminary data
supporting its safety in Alzheimer's disease (AD). Preclinical work in a mouse model that
develops both plaques and tangles supports the hypothesis that nicotinamide can act as a
histone deacetylase (HDAC) inhibitor to reduce phosphorylation of tau.

The study will implement a group sequential design, incorporating a futility analysis with a
go/no-go decision conditional on cerebral spinal fluid CSF biomarker outcomes at 12-months.
The primary outcome for the trial is change in p-tau231.

This study timeline includes a screening phase of up to 60 days and treatment phase which is
expected to last about 48 weeks and will include 4 study visits.

An additional 12-month treatment and follow-up period is planned, contingent upon a "go"
decision based on the primary outcome (CSF p-tau231) or one planned secondary outcome (CSF
p-tau181)

Inclusion 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
We found this trial at
2
sites
Irvine, California 92697
949-824-5011
Principal Investigator: Steven Tam, M.D.
Phone: 949-824-0008
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Sarah Kremen, M.D.
Phone: 310-794-6191
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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