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NCT00369785 · ClinicalTrials.gov registry record · Phase 3

Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors

A Phase 3 study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 3
Development phase
198
Enrollment target

NCT00369785: Completed Phase 3 study, sponsored by Wake Forest University Health Sciences.

NCT00369785 is a Phase 3 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 198 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00369785, a Phase 3 study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 3
Development phase
198 participants
Enrollment target

Study Summary

RATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of life in patients who have undergone radiation therapy for brain tumors. It is not yet known whether donepezil is more effective than a placebo in lessening side effects of radiation therapy in patients with brain tumors. PURPOSE: This randomized phase III trial is studying donepezil to see how well it works in lessening side effects of radiation therapy compared with a placebo in patients who have undergone radiation therapy for brain tumors.

Primary Outcome

Memory is quantified using the Hopkins Verbal Learning Test (HVLT) - immediate recall. Participants are asked to recall 12 words. Each recalled word is given one point. They are given three trials. The total score is the sum of the recalled words. The range for HVLT-Immediate recall is 0 to 36. Higher scores represent better memory.

Interventions

  • DRUG Placebo
  • DRUG donepezil hydrochloride

Trial Details

FieldValue
Enrollment Target 198 participants
Start Date 2008-02
Est. Completion 2012-07-01
Phase Phase 3
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT00369785 record still lists

NCT00369785 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).

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

NCT00369785 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00369785 about?

NCT00369785 is a clinical study titled "Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors". RATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of life in patients who have undergone radiation therapy for brain tumors. It is not yet known whether donepezil is more effective than a placebo in lessening side effects of radiation therapy in patients with br...

What is the current status of trial NCT00369785?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 198 participants. The study started on 2008-02. Estimated completion is 2012-07-01.

What interventions are being tested in trial NCT00369785?

The interventions under investigation include: Placebo (DRUG), donepezil hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00369785?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00369785's enrollment target sits among peer trials

198 1389th of 2000 higher than 611 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00369785, the US trial registry maintained by the National Library of Medicine. NCT00369785 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.