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NCT00369785 · OUTCOME

Memory as Quantified by HVLT-immediate Recall

Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors · Source last updated 2021-10-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
LEAST_SQUARES_MEAN
Unit
units on a scale
Interval / dispersion
Standard Error
Time frame
24 weeks

What was measured

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.

Analysis population: Participants with 24 week HVLT data.

Groups in this outcome

Arm I - Donepezil

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

Arm II - Control

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I - Donepezil72
Arm II - Control73

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I - Donepezil22.50.45Not reportedNot reportedNot reported
Arm II - Control22.20.45Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    Null Hypothesis: No difference in immediate recall memory at 24 weeks
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    .62
    p Value Comment
    Not adjusted for multiple comparisons.
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. group Description
    Null Hypothesis: No difference in immediate recall memory at 24 weeks
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    .62
    p Value Comment
    Not adjusted for multiple comparisons.
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.45
        value
        22.5
      2. group Id
        OG001
        spread
        0.45
        value
        22.2
denoms
  1. counts
    1. group Id
      OG000
      value
      72
    2. group Id
      OG001
      value
      73
    units
    Participants
description
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.
dispersion Type
Standard Error
groups
  1. description
    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
    id
    OG000
    title
    Arm I - Donepezil
  2. description
    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
    id
    OG001
    title
    Arm II - Control
param Type
LEAST_SQUARES_MEAN
population Description
Participants with 24 week HVLT data.
reporting Status
POSTED
time Frame
24 weeks
title
Memory as Quantified by HVLT-immediate Recall
type
PRIMARY
unit Of Measure
units on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice