Evidence map›Paper›PMID 21519001›Full record

Trial reportNeurology2011

Multicenter randomized clinical trial of donepezil for memory impairment in multiple sclerosis.

L B Krupp, C Christodoulou, P Melville, W F Scherl, L-Y Pai, L R Muenz, D He, R H B Benedict, A Goodman, S Rizvi and 4 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02988401 (Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis), which is not on this map. Cited by 46 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 5 pooled it
7.7field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02988401 phase1 / phase2completednot on this mapstarted 2017, after this paper: background citation

Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis

TypeinterventionalSponsorJohns Hopkins UniversityRan2017 to 2021Enrolled105ConditionsMultiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Primary ProgressiveArmsInsulin, Placebo (Sterile diluent)
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 5 syntheses or guidelines pooled it, 112 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pharmacological treatment for memory disorder in multiple sclerosis.The Cochrane database of systematic reviews · 2013
    Pooled it
  6. Intranasal insulin for improving cognitive function in multiple sclerosis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Pharmaceuticals (Basel, Switzerland) · 2024
    Article
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  16. Review
  17. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

L B KruppDepartment of Neurology, State University of New York at Stony Brook, Stony Brook, NY 11794-8121, USA. lauren.krupp@stonybrook.edu
C Christodoulou
P Melville
W F Scherl
L-Y Pai
L R Muenz
D He
R H B Benedict
A Goodman
S Rizvi
S R Schwid
B Weinstock-Guttman
H J Westervelt
H Wishart
University at Buffalo, State University of New York · US

Funding

World Trade Center Worker and Volunteer Medical Screening ProgramM01RR010710 · NCRR · STATE UNIVERSITY NEW YORK STONY BROOK · PI CHEN, WEN Y · 1998 to 2009
$17.6M
INTERVENTIONS TO IMPROVE MEMORY IN PATIENTS WITH MSR01HD038107 · NICHD · STATE UNIVERSITY NEW YORK STONY BROOK · PI KRUPP, LAUREN B · 1999 to 2006
$2.7M
NCRR NIH HHS M01 RR010710NICHD NIH HHS R01 HD038107
6 · The paper itself

Abstract

objectivesThe goal of this study was to determine if memory would be improved by donepezil as compared to placebo in a multicenter, double-blind, randomized clinical trial (RCT).

methodsDonepezil 10 mg daily was compared to placebo to treat memory impairment. Eligibility criteria included the following: age 18-59 years, clinically definite multiple sclerosis (MS), and performance ≤ ½ SD below published norms on the Rey Auditory Verbal Learning Test (RAVLT). Neuropsychological assessments were performed at baseline and 24 weeks. Primary outcomes were change on the Selective Reminding Test (SRT) of verbal memory and the participant's impression of memory change. Secondary outcomes included changes on other neuropsychological tests and the evaluating clinician's impression of memory change.

resultsA total of 120 participants were enrolled and randomized to either donepezil or placebo. No significant treatment effects were found between groups on either primary outcome of memory or any secondary cognitive outcomes. A trend was noted for the clinician's impression of memory change in favor of donepezil (37.7%) vs placebo (23.7%) (p = 0.097). No serious or unanticipated adverse events attributed to study medication developed.

conclusionsDonepezil did not improve memory as compared to placebo on either of the primary outcomes in this study. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence which does not support the hypothesis that 10 mg of donepezil daily for 24 weeks is superior to placebo in improving cognition as measured by the SRT in people with MS whose baseline RAVLT score was 0.5 SD or more below average.

Indexed as

AdolescentAdultCholinesterase InhibitorsDonepezilDouble-Blind MethodFemaleHumansIndansMaleMemory DisordersMiddle AgedMultiple SclerosisNeuropsychological TestsPiperidinesTreatment OutcomeVerbal LearningCholinesterase InhibitorsDonepezilIndansPiperidines

Identifiers

PMID21519001
PMCPMC3087469
OpenAlexW4242280770

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.