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 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: M23-5152022-501918-55-00
• Study Type: interventional
• Target: 263
• Locations: 7 countries
• Sites: 64

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)

Keywords

Alzheimer's disease (AD); Dementia; ABBV-552

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score at 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.

  Week 12

Study Arms (4)

ABBV-552: 1 mg

EXPERIMENTAL

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

Drug: ABBV-552

ABBV-552: 5 mg

EXPERIMENTAL

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

Drug: ABBV-552

ABBV-552: 15 mg

EXPERIMENTAL

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

Drug: ABBV-552

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo for ABBV-552

Interventions

ABBV-552 DRUG

Oral Capsule

ABBV-552: 1 mg; ABBV-552: 15 mg; ABBV-552: 5 mg

Placebo for ABBV-552 DRUG

Oral Capsule

Placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (64)

Irvine Clinical Research /ID# 250030

Irvine, California, 92614, United States

Location

Alliance for Research Alliance for Wellness /ID# 246492

Long Beach, California, 90807, United States

Location

Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 248891

Los Alamitos, California, 90720, United States

Location

New England Institute for Clinical Research /ID# 246488

Stamford, Connecticut, 06905, United States

Location

Vertex Research Group Inc /ID# 248295

Clermont, Florida, 34711-5037, United States

Location

Finlay Medical Research - West Palm Beach /ID# 246970

Greenacres City, Florida, 33467-2979, United States

Location

Velocity Clinical Research - Hallandale Beach /ID# 246896

Hallandale, Florida, 33009-4427, United States

Location

New Life Medical Research Center - Hialeah /ID# 247536

Hialeah, Florida, 33012, United States

Location

K2 Medical Research - The Villages /ID# 250820

Lady Lake, Florida, 32159-8975, United States

Location

Allied Biomedical Res Inst Inc /ID# 246971

Miami, Florida, 33155, United States

Location

Ivetmar Medical Group, LLC. /ID# 247670

Miami, Florida, 33155, United States

Location

New Horizon Research Center /ID# 248298

Miami, Florida, 33165-3372, United States

Location

K2 Medical Research - Ocoee /ID# 251029

Ocoee, Florida, 34761-4547, United States

Location

Health Synergy Clinical Research LLC /ID# 247726

Okeechobee, Florida, 34972-2568, United States

Location

K2 Medical Research - Orlando - South Orlando Avenue /ID# 250904

Orlando, Florida, 32751, United States

Location

Combined Research Orlando Phase I-IV /ID# 247697

Orlando, Florida, 32814, United States

Location

Alzheimer's Research and Treatment Center - Stuart /ID# 246484

Stuart, Florida, 34997-5765, United States

Location

Alzheimer's Research and Treatment Center - Wellington /ID# 246491

Wellington, Florida, 33414, United States

Location

Conquest Research /ID# 262078

Winter Park, Florida, 32789, United States

Location

Columbus Memory Center /ID# 249534

Columbus, Georgia, 31909, United States

Location

Northwest Clinical Trials /ID# 248663

Boise, Idaho, 83704, United States

Location

Indiana University Health, Inc. /ID# 248300

Fort Wayne, Indiana, 46804, United States

Location

Josephson-Wallack-Munshower Neurology - Northeast /ID# 248554

Indianapolis, Indiana, 46256, United States

Location

University of Kentucky Sanders-Brown Center on Aging /ID# 251139

Lexington, Kentucky, 40504, United States

Location

NeuroMedical Clinic of Central Louisiana /ID# 246960

Alexandria, Louisiana, 71301-3900, United States

Location

Tandem Clinical Research, LLC /ID# 246973

Marrero, Louisiana, 70072-3156, United States

Location

Adams Clinical /ID# 248358

Watertown, Massachusetts, 02472, United States

Location

Velocity Clinical Research, Inc /ID# 249837

Raleigh, North Carolina, 27607, United States

Location

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

Beavercreek, Ohio, 45432-2886, United States

Location

NeuroScience Research Center - Canton /ID# 248552

Canton, Ohio, 44718-2784, United States

Location

Neurology Diagnostics - South /ID# 246931

Dayton, Ohio, 45459-4296, United States

Location

Duplicate_Summit Headlands LLC /ID# 250678

Portland, Oregon, 97210, United States

Location

Vanderbilt Ingram Cancer Center /ID# 248801

Nashville, Tennessee, 37232-0021, United States

Location

Kerwin Medical Center /ID# 248662

Dallas, Texas, 75231-4316, United States

Location

ANESC Research LLC /ID# 246958

El Paso, Texas, 79912, United States

Location

Epic Medical Research /ID# 249141

Red Oak, Texas, 75154-3981, United States

Location

Sentara Neurology Specialists - Norfolk /ID# 248578

Norfolk, Virginia, 23510-1065, United States

Location

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

Darlinghurst, New South Wales, 2010, Australia

Location

Southern Neurology - Kogarah /ID# 249098

Kogarah, New South Wales, 2217, Australia

Location

Box Hill Hospital /ID# 249095

Box Hill, Victoria, 3128, Australia

Location

Australian Alzheimer's Res Fou /ID# 249097

Nedlands, Western Australia, 6009, Australia

Location

Universitaetsklinikum des Saarlandes /ID# 248077

Homburg, Saarland, 66424, Germany

Location

Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 248078

Berlin, 12203, Germany

Location

NHO Hiroshima-Nishi Medical center /ID# 256947

Otake-shi, Hiroshima, 739-0696, Japan

Location

Duplicate_Kawashima Neurology Clinic /ID# 253561

Fujisawa-shi, Kanagawa, 251-0038, Japan

Location

Shonan Kamakura General Hospital /ID# 256664

Kamakura-shi, Kanagawa, 247-8533, Japan

Location

Teikyo University Mizonokuchi Hospital /ID# 253259

Kawasaki, Kanagawa, 213-8507, Japan

Location

Nara Medical University Hospital /ID# 252564

Kashihara-shi, Nara, 634-8522, Japan

Location

NHO Niigata National Hospital /ID# 254207

Kashiwazaki-shi, Niigata, 945-8585, Japan

Location

Oita University Hospital /ID# 253679

Yufu, Oita Prefecture, 879-5503, Japan

Location

Hizen Psychiatric Center /ID# 252363

Kanzaki-gun, Saga-ken, 842-0192, Japan

Location

Juntendo University Hospital /ID# 252373

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

CGM Research Trust /ID# 249439

Christchurch Central, 8011, New Zealand

Location

Hospital Universitari General de Catalunya /ID# 249100

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Hospital Universitari Mútua Terrassa /ID# 248448

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitario Marques de Valdecilla /ID# 248454

Santander, Cantabria, 39008, Spain

Location

Clinica Universidad de Navarra - Pamplona /ID# 248415

Pamplona, Navarre, 31008, Spain

Location

Hospital Internacional Ruber - Grupo Quiron Salud /ID# 248856

Madrid, 28034, Spain

Location

Hospital Universitario de Salamanca /ID# 249101

Salamanca, 37711, Spain

Location

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

Motherwell, Lanarkshire, ML3 4UF, United Kingdom

Location

Re:Cognition Health Birmingham /ID# 249796

Birmingham, B16 8LT, United Kingdom

Location

Re:Cognition Health Bristol /ID# 249795

Bristol, BS32 4SY, United Kingdom

Location

St Pancras Clinical Research /ID# 249006

London, EC2Y 8EA, United Kingdom

Location

Re:Cognition Health - London /ID# 249005

London, W1G 9JF, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: June 5, 2023
• Primary Completion: August 6, 2024
• Study Completion: September 12, 2024
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

GB (5); AU (4); DE (2); US (37); JP (9); NZ (1); ES (6)