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

Phase 2

Completed

• Conditions: Alzheimer's Disease (AD)
• Interventions: Drug: ABBV-552; Drug: Placebo for ABBV-552

• Registration Number: NCT05771428
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-16
• Study Start: 2023-04-27
• Primary Completion: 2024-08-06
• Study Completion: 2024-09-12
• Disposition First Posted: 2024-10-24
• Status Verified: 2025-04
• Disposition First Submitted: 2025-04-01
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABBV-552 Dose C	ABBV-552	Participants will receive ABBV-552 Dose C QD for 12 weeks.
Placebo for ABBV-552	Placebo for ABBV-552	Participants will receive placebo for ABBV-552 QD for 12 weeks.
ABBV-552 Dose A	ABBV-552	Participants will receive ABBV-552 Dose A once daily (QD) for 12 weeks.
ABBV-552 Dose B	ABBV-552	Participants will receive ABBV-552 Dose B QD for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) score	From Baseline (Week 0) through Week 12	The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 \[1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task\] and includes 3 additional tasks \[12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning\], for increased sensitivity in mild cognitive impairment (MCI) patients. The Total Score of the ADAS-Cog-14 ranges from 0 to 90, with a higher score representing greater impairment.

Trial Locations

Locations (64)

Irvine Clinical Research /ID# 250030; 🇺🇸 Irvine, California, United States

Alliance for Research Alliance for Wellness /ID# 246492; 🇺🇸 Long Beach, California, United States

Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 248891; 🇺🇸 Los Alamitos, California, United States

New England Institute for Clinical Research /ID# 246488; 🇺🇸 Stamford, Connecticut, United States

Vertex Research Group Inc /ID# 248295; 🇺🇸 Clermont, Florida, United States

Finlay Medical Research - West Palm Beach /ID# 246970; 🇺🇸 Greenacres City, Florida, United States

Velocity Clinical Research - Hallandale Beach /ID# 246896; 🇺🇸 Hallandale Beach, Florida, United States

New Life Medical Research Center - Hialeah /ID# 247536; 🇺🇸 Hialeah, Florida, United States

K2 Medical Research - The Villages /ID# 250820; 🇺🇸 Lady Lake, Florida, United States

Allied Biomedical Res Inst Inc /ID# 246971; 🇺🇸 Miami, Florida, United States

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