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
Completed · Phase 2 · Has a placebo group
Conditions studied: Alzheimer's Disease (AD)
In brief
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.
Key facts
- Study ID
- NCT05771428
- Run by
- AbbVie
- People needed
- 263
- Starts
- 2023-06-05
- Expected to finish
- 2024-09-12
- Last updated by the study team
- 2025-10-15
Who can join
Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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, 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
- Ivetmar Medical Group, LLC. /ID# 247670 — Miami, Florida, United States
- New Horizon Research Center /ID# 248298 — Miami, Florida, United States
- K2 Medical Research - Ocoee /ID# 251029 — Ocoee, Florida, United States
- Health Synergy Clinical Research LLC /ID# 247726 — Okeechobee, Florida, United States
- K2 Medical Research - Orlando - South Orlando Avenue /ID# 250904 — Orlando, Florida, United States
- Combined Research Orlando Phase I-IV /ID# 247697 — Orlando, Florida, United States
- Alzheimer's Research and Treatment Center - Stuart /ID# 246484 — Stuart, Florida, United States
- Alzheimer's Research and Treatment Center - Wellington /ID# 246491 — Wellington, Florida, United States
- Conquest Research /ID# 262078 — Winter Park, Florida, United States
- Columbus Memory Center /ID# 249534 — Columbus, Georgia, United States
- Northwest Clinical Trials /ID# 248663 — Boise, Idaho, United States
- Indiana University Health, Inc. /ID# 248300 — Fort Wayne, Indiana, United States
- Josephson-Wallack-Munshower Neurology - Northeast /ID# 248554 — Indianapolis, Indiana, United States
- University of Kentucky Sanders-Brown Center on Aging /ID# 251139 — Lexington, Kentucky, United States
- NeuroMedical Clinic of Central Louisiana /ID# 246960 — Alexandria, Louisiana, United States
- Irvine Clinical Research /ID# 250030 — Irvine, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.