Overview

Nicotinamide as an Early Alzheimer's Disease Treatment

Status:
Recruiting

Trial end date:
2022-07-30

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of California, Irvine

Treatments:

Niacin
Niacinamide
Nicotinic Acids

Criteria

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