Phase 2
N=46
Nicotinamide as an Early Alzheimer's Disease Treatment
Alzheimer's Disease · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03061474 ↗Enrolled (actual)
46
Serious AEs
17.4%
Results posted
Oct 2023
Primary outcome: Primary: Change in P-tau 231 — 4.71; 2.28 pg/ml — p=0.6096
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nicotinamide (Drug); Placebo Comparator (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in P-tau 231 |
4.71; 2.28 | 0.6096 |
| PRIMARY Vital Signs - Weight |
76.39; 68.11; 76.29; 70.05; 77.27; 69.36 | — |
| PRIMARY Vital Signs - BMI |
26.35; 24.09; 26.33; 24.85; 26.42; 24.72 | — |
| PRIMARY Vital Signs - Systolic Blood Pressure |
134.67; 126.09; 137.42; 125.41; 133.36; 128.05 | — |
| PRIMARY Vital Signs - Diastolic Blood Pressure |
75.42; 71.32; 74.21; 70.45; 72.45; 71.4 | — |
| PRIMARY Vital Signs - Pulse |
56.42; 62.5; 59.33; 64.91; 58.86; 63.45 | — |
| PRIMARY Count of Treatment Emergent Adverse Events |
79; 71 | — |
| PRIMARY Count of Adverse Events by Severity |
49; 38; 27; 31; 3; 2 | — |
| PRIMARY Columbia-Suicide Severity Rating Scale |
0; 3; 1; 3 | — |
| PRIMARY ECG Abnormalities |
24; 20 | — |
| PRIMARY QTC Abnormalities |
2; 1 | — |
| PRIMARY Change in QTC |
6.41; 2.1 | — |
| SECONDARY Change in ab40 |
2307; 1961.1 | 0.648 |
| SECONDARY Change in ab42 |
127.74; 113.79 | 0.6833 |
| SECONDARY Change in P-tau 181 |
-0.41; -10.43 | 0.4438 |
| SECONDARY Change in Total Tau |
-8.42; -60.47 | 0.7158 |
| SECONDARY Change in Ratio of Total Tau/ab40 |
-0.02; -0.02 | 0.93428359 |
| SECONDARY Change in Ratio of Total Tau/ab42 |
-0.46; -0.5 | 0.9931 |
| SECONDARY ADASCog-13 |
3.2; 5.16 | 0.3233 |
| SECONDARY Activities of Daily Living - Mild Cognitive Impairment |
-4.05; -1.39 | 0.1008 |
| SECONDARY CDR Sum of Boxes |
0.76; 2.18 | 0.0323 sig |
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.
Eligibility Criteria
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) 4
- Magnetic Resonance Imaging (MRI) incompatibility
- MRI evidence of cortical stroke >1cm, superficial siderosis, or extensive white matter hyperintensity (Cardiovascular Health Study score 7-8+)
- Diagnosis of cancer in the previous 5 years (with the exception of basal or squamous cell 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 with study 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 in previous 6-months (time between last investigational drug administration and baseline for the current study)
- 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).
- Unwillingness to abstain from over-the-counter nicotinamide for the duration of the trial
Data sourced from ClinicalTrials.gov (NCT03061474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.