> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-assess-adverse-events-change-in-disease-activity-0ef29983-690d-4cb8-9b5e-fa43669a6b31 > Record changed: 2026-11-04 # 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 NCT05771428 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) Participants 263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) Start date 2023-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) Number of sites 64 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Acronym** Abroad Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Short 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) ## Dates **Completion date** 2024-09-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **First posted** 2023-03-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Registry last updated** 2025-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Primary completion date** 2024-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Start date** 2023-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) ## Size and sites **Actual participants** 263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Participants** 263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Number of sites** 64 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) ## Identifiers **Registry ID** NCT05771428 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **ClinicalTrials.gov ID** NCT05771428 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) ## Outcomes ### Primary outcomes 1. Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score at Week 12 Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 50 Years **Maximum age** 90 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) ## Sites - Irvine Clinical Research /ID# 250030Irvine, United States - Alliance for Research Alliance for Wellness /ID# 246492Long Beach, United States - Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 248891Los Alamitos, United States - New England Institute for Clinical Research /ID# 246488Stamford, United States - Vertex Research Group Inc /ID# 248295Clermont, United States - Finlay Medical Research - West Palm Beach /ID# 246970Greenacres City, United States - Velocity Clinical Research - Hallandale Beach /ID# 246896Hallandale, United States - New Life Medical Research Center - Hialeah /ID# 247536Hialeah, United States - K2 Medical Research - The Villages /ID# 250820Lady Lake, United States - Allied Biomedical Res Inst Inc /ID# 246971Miami, United States - Ivetmar Medical Group, LLC. /ID# 247670Miami, United States - New Horizon Research Center /ID# 248298Miami, United States - K2 Medical Research - Ocoee /ID# 251029Ocoee, United States - Health Synergy Clinical Research LLC /ID# 247726Okeechobee, United States - K2 Medical Research - Orlando - South Orlando Avenue /ID# 250904Orlando, United States - Combined Research Orlando Phase I-IV /ID# 247697Orlando, United States - Alzheimer's Research and Treatment Center - Stuart /ID# 246484Stuart, United States - Alzheimer's Research and Treatment Center - Wellington /ID# 246491Wellington, United States - Conquest Research /ID# 262078Winter Park, United States - Columbus Memory Center /ID# 249534Columbus, United States - Northwest Clinical Trials /ID# 248663Boise, United States - Indiana University Health, Inc. /ID# 248300Fort Wayne, United States - Josephson-Wallack-Munshower Neurology - Northeast /ID# 248554Indianapolis, United States - University of Kentucky Sanders-Brown Center on Aging /ID# 251139Lexington, United States - NeuroMedical Clinic of Central Louisiana /ID# 246960Alexandria, United States And 39 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) ## References ### Other registry identifiers - 2022-501918-55-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771428) ## Related records ### Drugs (1) - [Plosaracetam](https://trialight.com/data/asset/plosaracetam-2cd13ae3-2d1d-453f-9e32-1b3019fcdc0c.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Conditions (2) - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Primary condition - [Dementia](https://trialight.com/data/condition/dementia-c61efc95-c071-50d2-9df7-acb34b2a720c.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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