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NCT03061474 · ClinicalTrials.gov registry record · Phase 2

Nicotinamide as an Early Alzheimer's Disease Treatment

A Phase 2 study, sponsored by University of California, Irvine.

Completed
Registry status
Phase 2
Development phase
46
Enrollment target

NCT03061474: Completed Phase 2 study, sponsored by University of California, Irvine.

NCT03061474 is a Phase 2 study that has completed, run by University of California, Irvine. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03061474, a Phase 2 study, has completed, sponsored by University of California, Irvine.

COMPLETED
Registry status
Phase 2
Development phase
46 participants
Enrollment target

Study 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.

Primary Outcome

Change in key peptide in cerebrospinal fluid (CSF) from baseline to 48 weeks. Higher phosphorylated tau (p-tau) is associated with a severity of Alzheimer's disease pathology.

Interventions

  • DRUG Placebo Comparator
  • DRUG Nicotinamide

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2017-07-12
Est. Completion 2022-08-30
Phase Phase 2
University of California, Irvine

368 total trials

What the finished NCT03061474 record still lists

NCT03061474 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.

NCT03061474 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03061474 about?

NCT03061474 is a clinical study titled "Nicotinamide as an Early Alzheimer's Disease Treatment". 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) deme...

What is the current status of trial NCT03061474?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2017-07-12. Estimated completion is 2022-08-30.

What interventions are being tested in trial NCT03061474?

The interventions under investigation include: Placebo Comparator (DRUG), Nicotinamide (DRUG).

Who is sponsoring clinical trial NCT03061474?

This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03061474's enrollment target sits among peer trials

46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03061474, the US trial registry maintained by the National Library of Medicine. NCT03061474 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.