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NCT02769065 · ClinicalTrials.gov registry record · Phase 1

Study of TAK-071 in Healthy Participants and Participants With Mild Cognitive Impairment/Mild Alzheimer Disease and Relative Bioavailability (BA) and Food Effect of TAK-071 in Healthy Participants

A Phase 1 study, sponsored by Takeda.

Terminated
Registry status
Phase 1
Development phase
179
Enrollment target

NCT02769065: Clinical Trial Phase 1 study, sponsored by Takeda.

NCT02769065 is a Phase 1 study that was terminated before completion, run by Takeda. The registered enrollment target is 179 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (198% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02769065, a Phase 1 study, was terminated before completion, sponsored by Takeda.

TERMINATED
Registry status
Phase 1
Development phase
179 participants
Enrollment target

Study Summary

The purpose of this study was to assess the safety, tolerability, and pharmacokinetic (PK) of TAK-071 when administered as single rising dose (SRD) and multiple rising dose (MRD) orally in healthy participants and participants with mild cognitive impairment (MCI) or mild Alzheimer disease (AD).

Primary Outcome

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs or gets worse after receiving study drug.

Interventions

  • DRUG Donepezil
  • DRUG TAK-071
  • DRUG TAK-071 Placebo
  • DRUG Donepezil Placebo

Trial Details

FieldValue
Enrollment Target 179 participants
Start Date 2016-05-05
Est. Completion 2017-06-08
Phase Phase 1
Takeda

408 total trials

Why NCT02769065 stopped before completion

NCT02769065 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (198% higher).

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

NCT02769065 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02769065 about?

NCT02769065 is a clinical study titled "Study of TAK-071 in Healthy Participants and Participants With Mild Cognitive Impairment/Mild Alzheimer Disease and Relative Bioavailability (BA) and Food Effect of TAK-071 in Healthy Participants". The purpose of this study was to assess the safety, tolerability, and pharmacokinetic (PK) of TAK-071 when administered as single rising dose (SRD) and multiple rising dose (MRD) orally in healthy participants and participants with mild cognitive impairment (MCI) or mild Alzheimer disease (AD).

What is the current status of trial NCT02769065?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 179 participants. The study started on 2016-05-05. Estimated completion is 2017-06-08.

What interventions are being tested in trial NCT02769065?

The interventions under investigation include: Donepezil (DRUG), TAK-071 (DRUG), TAK-071 Placebo (DRUG), Donepezil Placebo (DRUG).

Who is sponsoring clinical trial NCT02769065?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02769065's enrollment target sits among peer trials

179 311th of 2000 higher than 1,690 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 NCT02769065, the US trial registry maintained by the National Library of Medicine. NCT02769065 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.