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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

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
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
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
Change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score
Timepoint [2] 0 0
At week 76
Secondary outcome [3] 0 0
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
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
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 = 20 to 28 (inclusive).
Minimum age
60 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
Central Coast Neuroscience Research - East Gosford - East Gosford
Recruitment hospital [2] 0 0
KaRa Institute of Neurological Disease Pty Ltd - Macquaire Park
Recruitment hospital [3] 0 0
Griffith University - Clinical Trial Unit - Gold Coast Campus - Griffith University
Recruitment hospital [4] 0 0
NeuroCentrix - Carlton North
Recruitment hospital [5] 0 0
Austin Health - Heidelberg Repatriation Hospital - Ivanhoe
Recruitment hospital [6] 0 0
HammondCare - Malvern
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Local Institution - 0147 - Parkville
Recruitment hospital [9] 0 0
Alzheimer's Research Australia - Nedlands
Recruitment postcode(s) [1] 0 0
2250 - East Gosford
Recruitment postcode(s) [2] 0 0
2113 - Macquaire Park
Recruitment postcode(s) [3] 0 0
4222 - Griffith University
Recruitment postcode(s) [4] 0 0
3053 - Carlton North
Recruitment postcode(s) [5] 0 0
3081 - Ivanhoe
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
03181 - Melbourne
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Arizona
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California
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Connecticut
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Illinois
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Massachusetts
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Ohio
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Pennsylvania
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Rhode Island
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Obu
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Osaka-shi
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Takatsuki-Shi
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Toride-Shi
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Seoul
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Gwangjingu
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Incheon
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Junggu
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Singapore
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Barcelona
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Uppsala Lan
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Huddinge
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SOM
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SRY
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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
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
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
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/disclosurecommitment.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/NCT06268886