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NCT00369785 · STUDY IN CONTEXT

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

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors-metastatic-2a1c1b0d
nct id
NCT00369785
trial label
Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
2
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-metastatic-2a1c1b0d
    nct id
    NCT00369785
    outcome key
    om-0000
    source section id
    NCT00369785-om-0000
    source outcome index
    0
    endpoint
    Memory as Quantified by HVLT-immediate Recall
    endpoint definition
    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.
    time origin
    24 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants with 24 week HVLT data.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-metastatic-2a1c1b0d
    nct id
    NCT00369785
    outcome key
    om-0001
    source section id
    NCT00369785-om-0001
    source outcome index
    1
    endpoint
    Memory as Quantified by the HVLT-discrimination
    endpoint definition
    In the Hopkins Verbal Learning Test - discrimination, participants are given lists of 12 correct words and 12 incorrect words. HVLT-discrimination is the number of correctly recognized words minus the number incorrectly recognized. The range for this outcome measure is -12 to 12. Higher scores represent better memory.
    time origin
    24 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Number of participants with 24 week memory data
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-metastatic-2a1c1b0d
    nct id
    NCT00369785
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I - Donepezil
    regimen
    Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00369785-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-metastatic-2a1c1b0d
    nct id
    NCT00369785
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II - Control
    regimen
    Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day
    analyzed count
    73
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00369785-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-metastatic-2a1c1b0d
    nct id
    NCT00369785
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I - Donepezil
    regimen
    Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00369785-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-metastatic-2a1c1b0d
    nct id
    NCT00369785
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II - Control
    regimen
    Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day
    analyzed count
    73
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00369785-om-0001#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-metastatic-2a1c1b0d
    nct id
    NCT00369785
    harm key
    EG000
    source section id
    NCT00369785-ae
    event group key
    EG000
    event group label
    Arm I - Donepezil
    serious affected
    12
    serious at risk
    96
    other affected
    88
    other at risk
    96
    frequency threshold
    5
    collection period
    24 weeks
    event definition
    Analysis includes everyone with post-treatment AE/toxicity data.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-metastatic-2a1c1b0d
    nct id
    NCT00369785
    harm key
    EG001
    source section id
    NCT00369785-ae
    event group key
    EG001
    event group label
    Arm II - Control
    serious affected
    10
    serious at risk
    92
    other affected
    80
    other at risk
    92
    frequency threshold
    5
    collection period
    24 weeks
    event definition
    Analysis includes everyone with post-treatment AE/toxicity data.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice