Evidence map›Paper›PMID 34095437›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2021

Intepirdine as adjunctive therapy to donepezil for mild-to-moderate Alzheimer's disease: A randomized, placebo-controlled, phase 3 clinical trial (MINDSET).

Frederick M Lang, Yi Mo, Marwan Sabbagh, Paul Solomon, Merce Boada, Roy W Jones, Giovanni B Frisoni, Timo Grimmer, Bruno Dubois, Mark Harnett and 3 more

Open access · goldAbstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
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  3. Review
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  5. PolyfunctionalizedInternational journal of molecular sciences · 2026
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  15. Alzheimer's disease drug development pipeline: 2021.Alzheimer's & dementia (New York, N. Y.) · 2021
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 7 countries.

Frederick M LangAxovant Sciences New York New York USA.
Yi MoAxovant Sciences New York New York USA.
Marwan SabbaghCleveland Clinic Lou Ruvo Center for Brain Health Las Vegas Nevada USA.
Paul SolomonBoston Center for Memory and Boston University Alzheimer's Disease Center Boston Massachusetts USA.
Merce BoadaResearch Center and Memory Clinic, Fundaciό ACE, Institut Català de Neurociències Aplicades Universitat Internacional de Catalunya Barcelona Spain.
Roy W JonesRICE (The Research Institute for the Care of Older People) Bath UK.
Giovanni B FrisoniLaboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy; Memory Clinic and LANVIE - Laboratory of Neuroimaging of Aging University Hospitals and University of Geneva Geneva Switzerland.
Timo GrimmerSchool of Medicine, Klinikum rechts der Isar Technical University of Munich Munich Germany.
Bruno DuboisDepartment of Neurology and Institute for Alzheimer's Disease (IM2A), Salpêtrière Hospital AP-HP, Sorbonne Université Paris France.
Mark HarnettAxovant Sciences New York New York USA.
Sarah R FriedhoffAxovant Sciences New York New York USA.
Shari CoslettAxovant Sciences New York New York USA.
Jeffrey L CummingsChambers-Grundy Center for Transformative Neuroscience Department of Brain Health, School of Integrated Health Sciences University of Nevada Las Vegas (UNLV) Las Vegas Nevada USA.
Myovant Sciences (United States) · USBiomedical Research Networking Center on Neurodegenerative Diseases · ESBoston University · USCentro San Giovanni di Dio Fatebenefratelli · ITCleveland Clinic · USRoivant Sciences (United States) · USSorbonne Université · FRTechnical University of Munich · DEThe Research Institute for the Care of Older People · GBUniversity of Nevada, Las Vegas · US

Funding

Renewal of Centers of Biomedical Research Excellence (COBRE) (Phase 2) CNTN - ResubmissionP20GM109025 · NIGMS · CLEVELAND CLINIC FOUNDATION · PI Robert J. Fox, Jefferson Kinney · 2015 to 2026
$22.8M
NVEDARC Clinical CoreP20AG068053 · NIA · CLEVELAND CLINIC FOUNDATION · PI WINT, DYLAN · 2020 to 2022
$3.3M
NIA NIH HHS P20 AG068053NIGMS NIH HHS P20 GM109025
6 · The paper itself

Abstract

introductionA previous phase 2b study supported the use of the 5-HT6 receptor antagonist intepirdine as adjunctive therapy to donepezil for Alzheimer's disease (AD) dementia. A phase 3 study, MINDSET, was performed to test this hypothesis.

methodsMINDSET was a global, double-blind, randomized, placebo-controlled trial in 1315 mild-to-moderate AD dementia patients on stable donepezil. Patients received 35 mg/day intepirdine or placebo for 24 weeks. The co-primary endpoints were change from baseline to week 24 on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).

resultsThere were no statistically significant differences between intepirdine and placebo groups (adjusted mean [95% confidence interval]) on the co-primary endpoints ADAS-Cog (-0.36 [-0.95, 0.22], DISCUSSION: Intepirdine as adjunctive therapy to donepezil did not produce statistical improvement over placebo on cognition or activities of daily living in mild-to-moderate AD dementia patients.

Indexed as

5‐HT6Alzheimer's diseaseclinical trialintepirdinephase 3

Identifiers

PMID34095437
PMCPMC8165732
OpenAlexW3168535286

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.