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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06976203




Registration number
NCT06976203
Ethics application status
Date submitted
9/05/2025
Date registered
16/05/2025
Date last updated
15/07/2025

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 2)
Secondary ID [1] 0 0
CN012-0052
Universal Trial Number (UTN)
Trial acronym
MINDSET 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KarXT
Treatment: Drugs - KarX-EC
Other interventions - Placebo

Active comparator: KarXT + KarX-EC -

Placebo comparator: Placebo -


Treatment: Drugs: KarXT
Specified dose on specified days

Treatment: Drugs: KarX-EC
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11)
Timepoint [1] 0 0
At week 24
Primary outcome [2] 0 0
Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+)
Timepoint [2] 0 0
At week 24
Secondary outcome [1] 0 0
Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL)
Timepoint [1] 0 0
At week 24
Secondary outcome [2] 0 0
Change from baseline in neuro psychiatric inventory (NPI) total score
Timepoint [2] 0 0
At week 24
Secondary outcome [3] 0 0
Number of participants with adverse events (AEs)
Timepoint [3] 0 0
At week 24
Secondary outcome [4] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [4] 0 0
At week 24
Secondary outcome [5] 0 0
Number of participants with adverse event of special interest (AESIs)
Timepoint [5] 0 0
At week 24
Secondary outcome [6] 0 0
Number of participants with AEs leading to study intervention discontinuation
Timepoint [6] 0 0
At week 24
Secondary outcome [7] 0 0
Number of participants with AEs leading to study discontinuation
Timepoint [7] 0 0
At week 24
Secondary outcome [8] 0 0
Number of participants with AEs leading to death
Timepoint [8] 0 0
At week 24
Secondary outcome [9] 0 0
Number of participants with clinically significant changes in vital signs
Timepoint [9] 0 0
At week 24
Secondary outcome [10] 0 0
Number of participants with clinically significant changes in electrocardiogram (ECG) tests
Timepoint [10] 0 0
At week 24
Secondary outcome [11] 0 0
Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS) tests
Timepoint [11] 0 0
At week 24
Secondary outcome [12] 0 0
Number of participants with clinically significant changes in weight
Timepoint [12] 0 0
At week 24
Secondary outcome [13] 0 0
Number of participants with clinically significant changes in safety laboratory tests
Timepoint [13] 0 0
At week 24

Eligibility
Key inclusion criteria
Inclusion Criteria

* Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.
* Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.
* Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.
* Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment.
* Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
* Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
* Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that could affect safety or interfere with study procedures.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
25/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/02/2029
Actual
Sample size
Target
586
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - 0055 - Brisbane
Recruitment hospital [2] 0 0
Local Institution - 0053 - Sippy Downs
Recruitment hospital [3] 0 0
Local Institution - 0056 - Southport
Recruitment hospital [4] 0 0
Local Institution - 0054 - Ivanhoe
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [3] 0 0
4222 - Southport
Recruitment postcode(s) [4] 0 0
3079 - Ivanhoe
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
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United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Argentina
State/province [14] 0 0
Ciudad Autónoma De Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Córdoba
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Mendoza
Country [18] 0 0
Brazil
State/province [18] 0 0
Ceará
Country [19] 0 0
Brazil
State/province [19] 0 0
Paraná
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio De Janeiro
Country [21] 0 0
Brazil
State/province [21] 0 0
São Paulo
Country [22] 0 0
Finland
State/province [22] 0 0
Pohjois-Pohjanmaa
Country [23] 0 0
Finland
State/province [23] 0 0
Uusimaa
Country [24] 0 0
Finland
State/province [24] 0 0
Varsinais-Suomi
Country [25] 0 0
Finland
State/province [25] 0 0
Helsinki
Country [26] 0 0
Finland
State/province [26] 0 0
Kuopio
Country [27] 0 0
France
State/province [27] 0 0
Alsace
Country [28] 0 0
France
State/province [28] 0 0
Bouches-du-Rhône
Country [29] 0 0
France
State/province [29] 0 0
Haute-Garonne
Country [30] 0 0
France
State/province [30] 0 0
Ille-et-Vilaine
Country [31] 0 0
France
State/province [31] 0 0
Meurthe-et-Moselle
Country [32] 0 0
France
State/province [32] 0 0
Nord-Pas-de-Calais
Country [33] 0 0
France
State/province [33] 0 0
Rhône
Country [34] 0 0
France
State/province [34] 0 0
Bordeaux
Country [35] 0 0
France
State/province [35] 0 0
Paris
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Germany
State/province [36] 0 0
Bayern
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Germany
State/province [37] 0 0
Hessen
Country [38] 0 0
Germany
State/province [38] 0 0
Niedersachsen
Country [39] 0 0
Germany
State/province [39] 0 0
Sachsen
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Germany
State/province [40] 0 0
Köln
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Germany
State/province [41] 0 0
Ulm
Country [42] 0 0
Greece
State/province [42] 0 0
Acha?a
Country [43] 0 0
Greece
State/province [43] 0 0
Attikí
Country [44] 0 0
Greece
State/province [44] 0 0
Ioánnina
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Greece
State/province [45] 0 0
Thessaloniki
Country [46] 0 0
Italy
State/province [46] 0 0
Campania
Country [47] 0 0
Italy
State/province [47] 0 0
Foggia
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Italy
State/province [48] 0 0
Roma
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Japan
State/province [49] 0 0
Kanagawa
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Japan
State/province [50] 0 0
Nagano
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Japan
State/province [51] 0 0
Niigata
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Japan
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Okayama
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Japan
State/province [53] 0 0
Osaka
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Japan
State/province [54] 0 0
Saga
Country [55] 0 0
Japan
State/province [55] 0 0
Saitama
Country [56] 0 0
Japan
State/province [56] 0 0
Kyoto
Country [57] 0 0
Netherlands
State/province [57] 0 0
Noord-Brabant
Country [58] 0 0
Netherlands
State/province [58] 0 0
Noord-Holland
Country [59] 0 0
Netherlands
State/province [59] 0 0
Overijssel
Country [60] 0 0
Poland
State/province [60] 0 0
Dolnoslaskie
Country [61] 0 0
Poland
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Lubelskie
Country [62] 0 0
Poland
State/province [62] 0 0
MA
Country [63] 0 0
Poland
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Slaskie
Country [64] 0 0
Portugal
State/province [64] 0 0
Lisboa
Country [65] 0 0
Portugal
State/province [65] 0 0
Porto
Country [66] 0 0
Portugal
State/province [66] 0 0
Braga
Country [67] 0 0
Portugal
State/province [67] 0 0
Coimbra
Country [68] 0 0
Portugal
State/province [68] 0 0
Guimarães
Country [69] 0 0
Puerto Rico
State/province [69] 0 0
Bayamon
Country [70] 0 0
Romania
State/province [70] 0 0
Bucure?ti
Country [71] 0 0
Romania
State/province [71] 0 0
Constan?a
Country [72] 0 0
Romania
State/province [72] 0 0
Sanpetru /Brasov
Country [73] 0 0
Spain
State/province [73] 0 0
Barcelona [Barcelona]
Country [74] 0 0
Spain
State/province [74] 0 0
Cantabria
Country [75] 0 0
Spain
State/province [75] 0 0
Madrid
Country [76] 0 0
Spain
State/province [76] 0 0
País Vasco
Country [77] 0 0
Spain
State/province [77] 0 0
Valenciana, Comunitat
Country [78] 0 0
United Kingdom
State/province [78] 0 0
England
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Leeds
Country [80] 0 0
United Kingdom
State/province [80] 0 0
London, City Of
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Midlothian
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Oxfordshire
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
8559073286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See plan description
Available to whom?
See plan description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06976203