Intepirdine as adjunctive therapy to donepezil for mild‐to‐moderate Alzheimer's disease: A randomized, placebo‐controlled, phase 3 clinical trial (MINDSET)
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Introduction: A 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. Methods: MINDSET 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). Results: There 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], P = 0.2249) and ADCS‐ADL (−0.09 [−0.90, 0.72], P = 0.8260). Intepirdine demonstrated a favorable safety profile similar to placebo. 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.
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Lack of diagnostic precision in these trials may contribute to commonly observed challenges including robust placebo responses and failure of placebo groups to decline.
“Lack of diagnostic precision in these trials may contribute to commonly observed challenges including robust placebo responses and failure of placebo groups to decline. 24 , 25”
From Alzheimer’s disease drug development pipeline: 2021 (2021) · cites this paper as [24]
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References 32 · Cited by 34
- Authors
- Lang, F. M., Mo, Y., Sabbagh, M., Solomon, P., Boada, M., Jones, R. W., Frisoni, G. B., Grimmer, T., Dubois, B., Harnett, M., Friedhoff, S. R., Coslett, S., & Cummings, J. L.
- Affiliations
- Columbia University Irving Medical Center (US)
- Axovant Sciences New York New York USA
- Cleveland Clinic (US)
- Boston University (US)
- Research Center and Memory Clinic, Fundaciό ACE, Institut Català de Neurociències Aplicades Universitat Internacional de Catalunya Barcelona Spain
- The Research Institute for the Care of Older People (GB)
- University of Geneva (CH)
- TUM Klinikum (DE)
- Sorbonne Université (FR)
- Roivant Sciences (United States) (US)
- University of Nevada, Las Vegas (US)
- Corresponding author
- Cummings, Jeffrey L.
- ORCID
- Venue
- Alzheimer's & Dementia: Translational Research & Clinical Interventions
- Publisher
- Wiley
- Published
- 2021-01
- Volume
- 7
- Issue
- 1
- Pages
- e12136-e12136
- ISSN
- 2352-8737 (ISSN-L)
- PMC
- PMC8165732
- OpenAlex
- W3168535286
- Cited by
- 34
- References
- 32
- Citations by year
- 2026: 4 · 2025: 9 · 2024: 9 · 2023: 6 · 2022: 4 · 2021: 2
- FWCI
- 3.77
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Alzheimer s & Dementia Translational Research & Clinical Interventions (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Digital Scholarship - UNLV (University of Nevada Reno) (submittedVersion, cc-by-nc-nd)
- HAL (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Archive ouverte UNIGE (University of Geneva) (submittedVersion, cc-by-nc-nd)
- Funders
- Agence Nationale de la Recherche (ANR-11-INBS-0011)
- National Institute on Aging (P20AG068053)
- National Institute of General Medical Sciences (P20GM109025)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Pharmacology › Cholinesterase and Neurodegenerative Diseases
- Keywords
- donepezil, Alzheimer's disease, adjunctive therapy, 5-HT6 receptor antagonists, mild to moderate dementia, cognitive function, activities of daily living, drug safety
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