Health Trials

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

ConditionAlzheimer's Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age55-90
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Amyloid PET.

Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.

Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).

History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Xanomeline/Trospium Chloride Capsule

    Drug

    Specified dose on specified days

  • Xanomeline Enteric Capsule

    Drug

    Specified dose on specified days

  • Placebo

    Drug

    Specified dose on specified days

Treatment groups

426 Participants
are divided into 2 treatment groups
Group A: KarXT + KarX-ECExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score at Week 14

Time frame
At Week 14

Secondary outcomes

1

Change from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14

Time frame
At Week 14
2

Change from baseline on CMAI-IPA Domains at Week 14

Time frame
At Week 14
3

Change from baseline on CMAI Total Score at Week 14

Time frame
At Week 14
4

Number of participants with Occurrence of Response at Week 14

As determined by CMAI-IPA changes of at least 30%, 40%, and 50% from baseline

Time frame
At Week 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
Apply now