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NCT01966666 · ClinicalTrials.gov registry record · Phase 1

A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TPI-287 in Alzheimer's Disease

A Phase 1 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target

NCT01966666: Completed Phase 1 study, sponsored by University of California, San Francisco.

NCT01966666 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01966666, a Phase 1 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

Study Summary

The purpose of the study is to determine the highest dose of TPI-287 that is safe and tolerable when administered as an intravenous infusion to participants with mild to moderate Alzheimer's disease (AD), to measure pharmacokinetic properties of the drug as well as to gauge preliminary efficacy of TPI-287 on disease progression.

Primary Outcome

Planned dose range of intravenous infusions of TPI-287 administered once every 3 weeks for 9 weeks. The dose will be escalated in 3 sequential cohorts and participants will be monitored for adverse events to determine safety and tolerability.

Interventions

  • DRUG Placebo
  • DRUG TPI-287 20 mg/m2
  • DRUG TPI-287 6.3 mg/m2
  • DRUG TPI-287 2 mg/m2

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2013-11
Est. Completion 2019-09
Phase Phase 1

What the finished NCT01966666 record still lists

NCT01966666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01966666 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01966666 about?

NCT01966666 is a clinical study titled "A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TPI-287 in Alzheimer's Disease". The purpose of the study is to determine the highest dose of TPI-287 that is safe and tolerable when administered as an intravenous infusion to participants with mild to moderate Alzheimer's disease (AD), to measure pharmacokinetic properties of the drug as well as to gauge preliminary efficacy of T...

What is the current status of trial NCT01966666?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2013-11. Estimated completion is 2019-09.

What interventions are being tested in trial NCT01966666?

The interventions under investigation include: Placebo (DRUG), TPI-287 20 mg/m2 (DRUG), TPI-287 6.3 mg/m2 (DRUG), TPI-287 2 mg/m2 (DRUG).

Who is sponsoring clinical trial NCT01966666?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01966666's enrollment target sits among peer trials

29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01966666, the US trial registry maintained by the National Library of Medicine. NCT01966666 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.