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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05771428




Registration number
NCT05771428
Ethics application status
Date submitted
6/03/2023
Date registered
16/03/2023
Date last updated
10/06/2024

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
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
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
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Germany
State/province [17] 0 0
Homburg
Country [18] 0 0
Japan
State/province [18] 0 0
Hiroshima
Country [19] 0 0
Japan
State/province [19] 0 0
Kanagawa
Country [20] 0 0
Japan
State/province [20] 0 0
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
Country [25] 0 0
New Zealand
State/province [25] 0 0
Christchurch Central
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Cantabria
Country [28] 0 0
Spain
State/province [28] 0 0
Navarra
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Salamanca
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Bristol, City Of
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Birmingham
Country [33] 0 0
United Kingdom
State/province [33] 0 0
London
Country [34] 0 0
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
Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most
common cause of dementia in the elderly population. Clinical symptoms of the disease may
begin with occasional forgetfulness such as misplacement of items, forgetting important dates
or events, and may progress to noticeable memory loss, increased confusion and agitation, and
eventually, loss of independence and non-responsiveness. This study will assess how safe and
effective ABBV-552 is in treating symptoms of early AD. Adverse events, change in disease
activity, how ABBV-552 moves through body of participants and the body response to ABBV-552
will be assessed.

ABBV-552 is an investigational drug being developed for the treatment of Alzheimer's disease
(AD). Study doctors put the participants in 1 of 4 groups (3 active dose groups and a placebo
group), called treatment arms. Each group receives a different treatment. There is a 1 in 4
chance that participants will be assigned to placebo. Approximately 240 participants aged
50-90 years with mild AD will be enrolled in approximately 60 sites across the world.

Participants will receive oral ABBV-552 or placebo capsules once daily for 12 weeks and
followed for 30 days after the last dose of study drug.

There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and completing questionnaires.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05771428
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