Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia

Conditions

• Agitation Associated With Alzheimer's Disease Dementia

Eligibility Criteria

Sex

ALL

Age

55 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• EXV-802 — DRUG
  Specified dose twice daily
• Placebo — DRUG
  Specified dose twice daily
• EXV-801 — DRUG
  Specified dose twice daily

Study Details

The goal of this clinical trial is to evaluate the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.

Key Dates

Start date

Feb 2, 2026

Status verified

Jun 2026

Primary completion

Jan 31, 2029

Completion

Feb 28, 2029

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: EXV-802
  Participants will be assigned to treatment with EXV-802 capsules administered twice a day over a 6-week period.
• Placebo Comparator: Placebo
  Participants will be assigned to treatment with placebo capsules administered twice a day over a 6-week period.
• Experimental: EXV-801
  Participants will be assigned to treatment with EXV-801 capsules administered twice a day over a 6-week period.

Primary Outcome Measure

Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory - International Psychogeriatric Association (CMAI-IPA) score [ Time Frame: Baseline to Week 6 ]

Central Contacts

• Exciva Clinical Studies
  +49 6221-6479990
  [email protected]

Locations (9)

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