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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06268886




Registration number
NCT06268886
Ethics application status
Date submitted
13/02/2024
Date registered
20/02/2024
Date last updated
14/06/2024

Titles & IDs
Public title
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Scientific title
A Randomized, Double-blind, Placebo-controlled, Global, Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease (TargetTau-1)
Secondary ID [1] 0 0
2023-504840-32-00
Secondary ID [2] 0 0
CN008-0003
Universal Trial Number (UTN)
Trial acronym
TargetTau-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease, Early Onset 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986446
Other interventions - Placebo

Placebo comparator: Placebo -

Experimental: BMS-986446 Dose A -

Experimental: BMS-986446 Dose B -


Treatment: Drugs: BMS-986446
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
Mean change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score
Timepoint [1] 0 0
At week 76
Secondary outcome [1] 0 0
Mean change from baseline in brain tau deposition as measured by tau positron emission tomography (PET)
Timepoint [1] 0 0
At week 76
Secondary outcome [2] 0 0
Mean change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score
Timepoint [2] 0 0
At week 76
Secondary outcome [3] 0 0
Mean change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score
Timepoint [3] 0 0
At week 76
Secondary outcome [4] 0 0
Mean change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score
Timepoint [4] 0 0
At week 76
Secondary outcome [5] 0 0
Mean change from baseline in Mini Mental State Examination (MMSE) score
Timepoint [5] 0 0
At week 76

Eligibility
Key inclusion criteria
Inclusion Criteria

* Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria.
* Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline.
* Evidence of AD pathology.
* Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II).
* Mini Mental Status Examination (MMSE) score = 22 to 30 (inclusive).
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Any evidence of a condition that may affect cognition other than AD.
* Contraindications to PET imaging.
* Inability to tolerate or contraindication to magnetic resonance imaging.
* Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments.
* Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening.
* 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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/11/2027
Actual
Sample size
Target
475
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0002 - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - 0111 - East Gosford
Recruitment hospital [3] 0 0
Local Institution - 0170 - Macquarie Park
Recruitment hospital [4] 0 0
Local Institution - 0116 - Southport
Recruitment hospital [5] 0 0
Local Institution - 0115 - Carlton North
Recruitment hospital [6] 0 0
Local Institution - 0093 - Heidelberg
Recruitment hospital [7] 0 0
Local Institution - 0001 - Malvern
Recruitment hospital [8] 0 0
Local Institution - 0125 - Melbourne
Recruitment hospital [9] 0 0
Local Institution - 0147 - Parkville
Recruitment hospital [10] 0 0
Local Institution - 0094 - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2250 - East Gosford
Recruitment postcode(s) [3] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
3053 - Carlton North
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
03181 - Melbourne
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Massachusetts
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Missouri
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Virginia
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Wisconsin
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Brussels
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Brussel
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VWV
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WLG
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Leuven
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Ontario
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Quebec
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France
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Limoges cedex
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France
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Rouen
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France
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Toulouse
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Japan
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Aichi
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Tokyo
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Chuo-Ku
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Hachioji-Shi
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Himeji-shi
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Kasukabe-Shi
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Kodaira-Shi
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Kurashiki-Shi
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Musashimurayama-Shi
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Musashino-Shi
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Nagoya-Shi
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Osaka-shi
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Toride-Shi
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Toyonaka-Shi
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Korea, Republic of
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Seoul
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Korea, Republic of
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Gwangjingu
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Korea, Republic of
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Incheon
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Junggu
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Netherlands
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NB
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Netherlands
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NH
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Singapore
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B
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CT
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Barcelona
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M
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Uppsala Lan
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Sweden
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Huddinge
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HAM
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United Kingdom
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LND
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SRY
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United Kingdom
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Bristol

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.
Trial website
https://clinicaltrials.gov/study/NCT06268886
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
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06268886