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Alzheimer’s disease · Drug research
The registry reports recruiting. This is trial metadata, not an assessment of treatment benefit.
Evidence 1Content updated Oct 28, 2026 · Sources last checked Oct 28, 2026
Inclusion Criteria * Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. * The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation. * History of agitation with onset at least four weeks prior to Screening. * MMSE-1 score ≤24. * NPI-NH agitation/aggression sub-score ≥ 4. * Stable living environment for at least 6 weeks prior to Screening. Participants are eligible if they are in nursing homes, assisted living facilities, or living at home and have an identified study partner (caregiver). * Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable. Exclusion Criteria * Clinically significant delusions/hallucinations requiring hospitalization. * History of bipolar disorder, schizophrenia, or schizoaffective disorder. * History of major depressive episode with psychotic features during the 12 months prior to Screening. * History of delirium within 30 days of Screening. * Other protocol-defined Inclusion/Exclusion criteria apply.
This record covers only the linked trial population. This registry-based page does not review FDA approval or labeling.
FDA approval not reviewed here
Alzheimer’s disease
See FDA labeling for the approved population and indication; this page covers the trial population only.
FDA labeling has not been reviewed for this page. This does not mean the treatment is unapproved.
Approval is specific to the indication and population. It does not establish availability, reimbursement or suitability for an individual.
Enrollment status comes from the registry; check the original record for current details.
Read trial record and posted resultsStudy ages: 55 Years to 90 Years. Other eligibility criteria apply; see the full criteria above.
Study countries and territories (including sites that may be closed): Argentina, Australia, China, United States.
Sites marked recruiting: United States. Check the original registry record for locations and study-team contacts; overall recruiting status does not guarantee a local place.
Primary data collection: Nov 26, 2027 (estimated). This is not a results-release date.
No results-posting date in this record.
Evidence 1registry · Registry metadata is submitted by the sponsor or responsible party and does not independently validate efficacy.
No posted registry results are indicated in this source response. This does not establish that no results exist elsewhere.
Limitations: Outcomes, effect estimates, uncertainty and study quality have not been appraised. Consult original results and publications.
Evidence 1Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
registry · NCT06808984 · Structured source fields
Source date: Oct 6, 2026 · Checked: Oct 28, 2026
Evidence location: protocolSection: identificationModule, statusModule, conditionsModule, armsInterventionsModule, designModule, outcomesModule, eligibilityModule, contactsLocationsModule, sponsorCollaboratorsModule; hasResults
Status: RECRUITING. Phase: PHASE2. Conditions: Agitation; Alzheimer Disease.
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