A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
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.
Inclusion Criteria
- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.
ii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.
B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:
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).
Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:
i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.
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).
AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).
CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).
Exclusion Criteria
- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.
ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.
- Prior/Concomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).
A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.
B. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).
C. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Clinical.Trials@bms.com855-907-3286
Scottsdale, Arizona 85258, United States
480-290-1547
Princeton, New Jersey 08540, United States
Woodmere, New York 11598-1739, United States
Buenos Aires, C1428AQK, Argentina
Porto Alegre, Rio Grande do Sul 90430-001, Brazil
Razgrad, 7200, Bulgaria
Beijing, Beijing Municipality 100088, China
Haidian District, Beijing Municipality 100191, China
+86-10-82806167
Chongqing, Chongqing Municipality 630014, China
Guangzhou, Guangdong 0, China
Guangzhou, Guangzhou Province 510260, China
Xian, Shanxi 710061, China
Chaïdári, Attikí 124 62, Greece
Kanzaki-Gun Yoshinogari-Cho, Saga-ken 842-0192, Japan
0952523231
Karatsu-shi, Saga-ken 847-0031, Japan
0955770711
Bunkyo-ku, Tokyo 113-8603, Japan
Lisbon, 1649-035, Portugal
Bucharest, 40874, Romania
Sanpetru /Brasov, 507190, Romania
40724993329
Salamanca, 37007, Spain
Kaohsiung Niao Sung Dist, Kaohsiung 83301, Taiwan
714-999-6688
925-298-5147
786-681-4959
407-440-4493
386-304-7070
301-251-4702
413-281-0577
508-925-7403
412-916-2425
248-687-7412
760-758-2222
845-674-9398
516-239-1800
918-645-5400
505-903-1715
801-288-0607
413-281-0575
509-458-7720
93515339477
5491144704855
543515000000
+5493517481586
55-6199983-1080
+5541988668732
5541999260355
+55 51 999885851
5551991019123
(5519)32670023
5521999822072
5511971539018
551159087222
360+11
+359 88 991 2216
35929702117
35952555695
519-685-8500 x77024
416-480-6100 x4551
416-535-8501 x32589
905-430-4055 x6268
+8613811021432
+861361823653
+861392221423
8613632587615
+862081332621
073189753041
+86 13914764479
+861898060171
+862288188006
+86 13957162835
+86 138 0573 6335
8613944802410
+385 98 369 555
38598422557
+306932447636
+302107796309
+302105832473
+306936608887
+30 694 291 8933
0722294882
+81-92-811-1821
+5218441258992
3316546308
5218182528996
525553627780
351239400448
253540330
3512178050x50
3519123604x24
+351261330700
0040757243543
+40727818190
0040731581100
0040745974029
+40721243869
0040723671301
+40745588989
4024151078x3
+40744518195
+40723000227
+34 630 070 877
966 616 805
+34914211218
675 486 977
+34948255400
+34639754620
+34654566812
+34937365050ext13939
+34679279973
+34670492099