A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)

ConditionAlzheimer 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

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

Treatments tested in this trial

Xanomeline/Trospium Chloride Capsule
Xanomeline Enteric Capsule
Placebo

Treatment groups

426 Participants

are divided into 2 treatment groups

Locations

158

Argentina

Local Institution - 10011900, La PlataBuenos Aires, Argentina

Local Institution - 1002B7602CBM, Mar del PlataBuenos Aires, Argentina

CEN Centro Especializado en Neurociencias5004, CórdobaCórdoba Province, Argentina

Fundacion Estudios ClinicosS2000DEJ, RosarioSanta Fe Province, Argentina

Sponsors and collaborators

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov