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

NCT ID: NCT05771428

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 263 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2024-09-12

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.

Conditions

Alzheimer's Disease (AD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ABBV-552: 1 mg

Participants will receive 1 mg of ABBV-552 once daily (QD) for 12 weeks.

Group Type: EXPERIMENTAL

ABBV-552

Intervention Type: DRUG

Oral Capsule

ABBV-552: 5 mg

Participants will receive 5 mg of ABBV-552 QD for 12 weeks.

Group Type: EXPERIMENTAL

ABBV-552

Intervention Type: DRUG

Oral Capsule

ABBV-552: 15 mg

Participants will receive 5 mg of ABBV-552 QD for 12 weeks.

Group Type: EXPERIMENTAL

ABBV-552

Intervention Type: DRUG

Oral Capsule

Placebo

Participants will receive placebo for ABBV-552 QD for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo for ABBV-552

Intervention Type: DRUG

Oral Capsule

Interventions

ABBV-552

Oral Capsule

Intervention Type: DRUG

Placebo for ABBV-552

Oral Capsule

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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, 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

Tandem Clinical Research, LLC /ID# 246973

Marrero, Louisiana, United States

Adams Clinical /ID# 248358

Watertown, Massachusetts, United States

Velocity Clinical Research, Inc /ID# 249837

Raleigh, North Carolina, United States

American Clinical Research Institute (ACRI) - Beavercreek /ID# 246930

Beavercreek, Ohio, United States

NeuroScience Research Center - Canton /ID# 248552

Canton, Ohio, United States

Neurology Diagnostics - South /ID# 246931

Dayton, Ohio, United States

Duplicate_Summit Headlands LLC /ID# 250678

Portland, Oregon, United States

Vanderbilt Ingram Cancer Center /ID# 248801

Nashville, Tennessee, United States

Kerwin Medical Center /ID# 248662

Dallas, Texas, United States

ANESC Research LLC /ID# 246958

El Paso, Texas, United States

Epic Medical Research /ID# 249141

Red Oak, Texas, United States

Sentara Neurology Specialists - Norfolk /ID# 248578

Norfolk, Virginia, United States

St Vincent's Centre for Applied Medical Research /ID# 249843

Darlinghurst, New South Wales, Australia

Southern Neurology - Kogarah /ID# 249098

Kogarah, New South Wales, Australia

Box Hill Hospital /ID# 249095

Box Hill, Victoria, Australia

Australian Alzheimer's Res Fou /ID# 249097

Nedlands, Western Australia, Australia

Universitaetsklinikum des Saarlandes /ID# 248077

Homburg, Saarland, Germany

Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 248078

Berlin, , Germany

NHO Hiroshima-Nishi Medical center /ID# 256947

Otake-shi, Hiroshima, Japan

Duplicate_Kawashima Neurology Clinic /ID# 253561

Fujisawa-shi, Kanagawa, Japan

Shonan Kamakura General Hospital /ID# 256664

Kamakura-shi, Kanagawa, Japan

Teikyo University Mizonokuchi Hospital /ID# 253259

Kawasaki, Kanagawa, Japan

Nara Medical University Hospital /ID# 252564

Kashihara-shi, Nara, Japan

NHO Niigata National Hospital /ID# 254207

Kashiwazaki-shi, Niigata, Japan

Oita University Hospital /ID# 253679

Yufu, Oita Prefecture, Japan

Hizen Psychiatric Center /ID# 252363

Kanzaki-gun, Saga-ken, Japan

Juntendo University Hospital /ID# 252373

Bunkyo-ku, Tokyo, Japan

CGM Research Trust /ID# 249439

Christchurch Central, , New Zealand

Hospital Universitari General de Catalunya /ID# 249100

Sant Cugat del Vallès, Barcelona, Spain

Hospital Universitari Mútua Terrassa /ID# 248448

Terrassa, Barcelona, Spain

Hospital Universitario Marques de Valdecilla /ID# 248454

Santander, Cantabria, Spain

Clinica Universidad de Navarra - Pamplona /ID# 248415

Pamplona, Navarre, Spain

Hospital Internacional Ruber - Grupo Quiron Salud /ID# 248856

Madrid, , Spain

Hospital Universitario de Salamanca /ID# 249101

Salamanca, , Spain

NeuroClin Limited(Previously Glasgow Memory Clinic) /ID# 249787

Motherwell, Lanarkshire, United Kingdom

Re:Cognition Health Birmingham /ID# 249796

Birmingham, , United Kingdom

Re:Cognition Health Bristol /ID# 249795

Bristol, , United Kingdom

St Pancras Clinical Research /ID# 249006

London, , United Kingdom

Re:Cognition Health - London /ID# 249005

London, , United Kingdom

Countries

United States; Australia; Germany; Japan; New Zealand; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.abbvieclinicaltrials.com/study/?id=M23-515

Related Info

Other Identifiers

2022-501918-55-00

Identifier Type: OTHER

Identifier Source: secondary_id

M23-515

Identifier Type: -

Identifier Source: org_study_id