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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05771428




Registration number
NCT05771428
Ethics application status
Date submitted
6/03/2023
Date registered
16/03/2023

Titles & IDs
Public title
Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-552 Capsules Moves Through the Body of Participants Aged 50 to 90 Years With Mild Alzheimer's Disease
Scientific title
A Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-552 in Participants With Mild Alzheimer's Disease
Secondary ID [1] 0 0
2022-501918-55-00
Secondary ID [2] 0 0
M23-515
Universal Trial Number (UTN)
Trial acronym
Abroad
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease (AD) 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 - ABBV-552
Treatment: Drugs - Placebo for ABBV-552

Experimental: ABBV-552 Dose A - Participants will receive ABBV-552 Dose A once daily (QD) for 12 weeks.

Experimental: ABBV-552 Dose B - Participants will receive ABBV-552 Dose B QD for 12 weeks.

Experimental: ABBV-552 Dose C - Participants will receive ABBV-552 Dose C QD for 12 weeks.

Placebo comparator: Placebo for ABBV-552 - Participants will receive placebo for ABBV-552 QD for 12 weeks.


Treatment: Drugs: ABBV-552
Oral Capsule

Treatment: Drugs: Placebo for ABBV-552
Oral Capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) score
Timepoint [1] 0 0
From Baseline (Week 0) through Week 12

Eligibility
Key inclusion criteria
* Diagnosis of probable Alzheimer's disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) (2011) criteria.
* Mini-Mental State Examination (MMSE) score of 20 to 26, a Clinical Dementia Rating (CDR) global score of 0.5 or 1.0, with a CDR memory score of 0.5 or higher, and at least 1 CDR functional domain (community affairs, home and hobbies, or personal care) score of 0.5 or higher at Screening Visit 1.
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinically significant and/or unstable medical conditions or any other reason that the investigator determines would interfere with participation in this study (e.g., unlikely to adhere to the study or procedures, keep appointments, or is planning to relocate during the study) or would make the participant an unsuitable candidate to receive ABBV-552.

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/09/2024
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Centre for Applied Medical Research /ID# 249843 - Darlinghurst
Recruitment hospital [2] 0 0
Southern Neurology - Kogarah /ID# 249098 - Kogarah
Recruitment hospital [3] 0 0
Box Hill Hospital /ID# 249095 - Box Hill
Recruitment hospital [4] 0 0
Australian Alzheimer's Res Fou /ID# 249097 - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Germany
State/province [16] 0 0
Berlin
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Germany
State/province [17] 0 0
Homburg
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Japan
State/province [18] 0 0
Hiroshima
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Japan
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Kanagawa
Country [20] 0 0
Japan
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Nara
Country [21] 0 0
Japan
State/province [21] 0 0
Niigata
Country [22] 0 0
Japan
State/province [22] 0 0
Oita
Country [23] 0 0
Japan
State/province [23] 0 0
Saga
Country [24] 0 0
Japan
State/province [24] 0 0
Tokyo
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New Zealand
State/province [25] 0 0
Christchurch Central
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Navarra
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Spain
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Madrid
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Spain
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Salamanca
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United Kingdom
State/province [31] 0 0
Bristol, City Of
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United Kingdom
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Birmingham
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United Kingdom
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London
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United Kingdom
State/province [34] 0 0
Motherwell

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


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/NCT05771428