RecruitingPhase 3

Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Masupirdine (SUVN-502) for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type

Lead sponsor

Suven Life Sciences Limited

Asset

Masupirdine

Listed sites

Recruiting sites

Enrollment

375

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 8-24

Primary endpoint

•Cohen-Mansfield Agitation Inventory (CMAI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2021-003405-22

Org study IDCTP3S1502HT6

NCT IDNCT05397639

Timeline

Milestones

Study first posted2022-05-31actual

Study start2022-11-01actual

Last update posted2026-01-12actual

Primary completion2026-12estimated (month precision)

Study completion2026-12estimated (month precision)

Assets

Drug assets

Masupirdine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Has a diagnosis of dementia of the Alzheimer's type according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.

•Has confirmed agitation using the IPA Consensus Provisional Definition of Agitation in Cognitive Disorders.

•Has a score between 8 and 24 (both inclusive) on Mini-Mental State Examination (MMSE)

Exclusion criteria

•Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, parkinson's disease, lewy body disease, frontotemporal dementia)

•Has symptoms of agitation that are not secondary to Alzheimer's disease (eg, pain, other psychiatric disorder, or delirium due to a metabolic disorder, systemic infection, or substance-induced).

•Participant (or caregiver) is deemed otherwise ineligible for participation in this study in the investigator's judgement.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Cohen-Mansfield Agitation Inventory (CMAI)

Time frame:From Baseline to Week 12 visit

change from baseline, improvement

Secondary/protocol endpoint

Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C)

Time frame:From Baseline to Week 12 visit

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.