Masupirdine for Agitation in Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+62 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Suven Life Sciences Limited

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial will test a medication called masupirdine, which participants will take regularly. It targets people with Alzheimer's disease who are experiencing agitation. The study aims to see if masupirdine can help reduce agitation and ensure it is safe and well-tolerated. Masupirdine has been previously evaluated in patients with moderate Alzheimer's disease and was found to be generally safe and well-tolerated.

Research Team

Eligibility Criteria

This trial is for people with Alzheimer's dementia who are experiencing agitation. Participants should score between 8 and 24 on the MMSE, indicating a certain level of cognitive function, and have their agitation confirmed by specific criteria. It's not for those whose agitation might be due to other medical issues or psychiatric disorders unrelated to Alzheimer's.

Inclusion Criteria

I have been diagnosed with Alzheimer's disease.

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

See 2 more

Exclusion Criteria

My agitation is not caused by Alzheimer's, pain, psychiatric disorders, infections, or substances.

Treatment Details

Interventions

Masupirdine (Other)

Trial OverviewThe study tests masupirdine at two different doses (50 mg and 100 mg) against a placebo to see if it can safely reduce agitation in Alzheimer’s patients. The trial will also look into how the body processes the drug.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low Dose Masupirdine ArmExperimental Treatment1 Intervention

Tablet

Group II: High Dose Masupirdine ArmExperimental Treatment1 Intervention

Tablet

Group III: PlaceboPlacebo Group1 Intervention

Tablet