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

JRCT ID: jRCT2071230035

Registered date:01/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Mild Alzheimer's Disease
• Date of first enrollment: 05/06/2023
• Target sample size: 240
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc :ABBV-552
Administration route: Oral Capsule

-Experimental: ABBV-552 Dose A
Participants will receive ABBV-552 Dose A once daily (QD) for 12 weeks.
Intervention: Drug: ABBV-552
-Experimental: ABBV-552 Dose B
Participants will receive ABBV-552 Dose B QD for 12 weeks.
Intervention: Drug: ABBV-552
-Experimental: ABBV-552 Dose C
Participants will receive ABBV-552 Dose C QD for 12 weeks.
Intervention: Drug: ABBV-552
-Placebo Comparator: Placebo for ABBV-552
Participants will receive placebo for ABBV-552 QD for 12 weeks.
Intervention: Drug: Placebo for ABBV-552

Outcome(s)

Primary Outcome

1.Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) score
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.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

-Adult males and females aged 50 to 90 years at the time of informed consent.
-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.

• Exclude 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.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT05771428