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 (Abroad)

September 26, 2025 updated by: AbbVie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Centre for Applied Medical Research /ID# 249843
      • Kogarah, New South Wales, Australia, 2217
        • Southern Neurology - Kogarah /ID# 249098
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital /ID# 249095
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Australian Alzheimer's Res Fou /ID# 249097
  • Germany
      • Berlin, Germany, 12203
        • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 248078
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Universitaetsklinikum des Saarlandes /ID# 248077
  • Japan
    • Hiroshima
      • Otake-shi, Hiroshima, Japan, 739-0696
        • NHO Hiroshima-Nishi Medical center /ID# 256947
    • Kanagawa
      • Fujisawa-shi, Kanagawa, Japan, 251-0038
        • Duplicate_Kawashima Neurology Clinic /ID# 253561
      • Kamakura-shi, Kanagawa, Japan, 247-8533
        • Shonan Kamakura General Hospital /ID# 256664
      • Kawasaki, Kanagawa, Japan, 213-8507
        • Teikyo University Mizonokuchi Hospital /ID# 253259
    • Nara
      • Kashihara-shi, Nara, Japan, 634-8522
        • Nara Medical University Hospital /ID# 252564
    • Niigata
      • Kashiwazaki-shi, Niigata, Japan, 945-8585
        • NHO Niigata National Hospital /ID# 254207
    • Oita Prefecture
      • Yufu, Oita Prefecture, Japan, 879-5503
        • Oita University Hospital /ID# 253679
    • Saga-ken
      • Kanzaki-gun, Saga-ken, Japan, 842-0192
        • Hizen Psychiatric Center /ID# 252363
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 252373
  • New Zealand
      • Christchurch Central, New Zealand, 8011
        • CGM Research Trust /ID# 249439
  • Spain
      • Madrid, Spain, 28034
        • Hospital Internacional Ruber - Grupo Quiron Salud /ID# 248856
      • Salamanca, Spain, 37711
        • Hospital Universitario de Salamanca /ID# 249101
    • Barcelona
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Hospital Universitari General de Catalunya /ID# 249100
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitari Mútua Terrassa /ID# 248448
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla /ID# 248454
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona /ID# 248415
  • United Kingdom
      • Birmingham, United Kingdom, B16 8LT
        • Re:Cognition Health Birmingham /ID# 249796
      • Bristol, United Kingdom, BS32 4SY
        • Re:Cognition Health Bristol /ID# 249795
      • London, United Kingdom, EC2Y 8EA
        • St Pancras Clinical Research /ID# 249006
      • London, United Kingdom, W1G 9JF
        • Re:Cognition Health - London /ID# 249005
    • Lanarkshire
      • Motherwell, Lanarkshire, United Kingdom, ML3 4UF
        • NeuroClin Limited(Previously Glasgow Memory Clinic) /ID# 249787
  • United States
    • California
      • Irvine, California, United States, 92614
        • Irvine Clinical Research /ID# 250030
      • Long Beach, California, United States, 90807
        • Alliance for Research Alliance for Wellness /ID# 246492
      • Los Alamitos, California, United States, 90720
        • Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 248891
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • New England Institute for Clinical Research /ID# 246488
    • Florida
      • Clermont, Florida, United States, 34711-5037
        • Vertex Research Group Inc /ID# 248295
      • Greenacres City, Florida, United States, 33467-2979
        • Finlay Medical Research - West Palm Beach /ID# 246970
      • Hallandale, Florida, United States, 33009-4427
        • Velocity Clinical Research - Hallandale Beach /ID# 246896
      • Hialeah, Florida, United States, 33012
        • New Life Medical Research Center - Hialeah /ID# 247536
      • Lady Lake, Florida, United States, 32159-8975
        • K2 Medical Research - The Villages /ID# 250820
      • Miami, Florida, United States, 33155
        • Allied Biomedical Res Inst Inc /ID# 246971
      • Miami, Florida, United States, 33165-3372
        • New Horizon Research Center /ID# 248298
      • Miami, Florida, United States, 33155
        • Ivetmar Medical Group, LLC. /ID# 247670
      • Ocoee, Florida, United States, 34761-4547
        • K2 Medical Research - Ocoee /ID# 251029
      • Okeechobee, Florida, United States, 34972-2568
        • Health Synergy Clinical Research LLC /ID# 247726
      • Orlando, Florida, United States, 32751
        • K2 Medical Research - Orlando - South Orlando Avenue /ID# 250904
      • Orlando, Florida, United States, 32814
        • Combined Research Orlando Phase I-IV /ID# 247697
      • Stuart, Florida, United States, 34997-5765
        • Alzheimer's Research and Treatment Center - Stuart /ID# 246484
      • Wellington, Florida, United States, 33414
        • Alzheimer's Research and Treatment Center - Wellington /ID# 246491
      • Winter Park, Florida, United States, 32789
        • Conquest Research /ID# 262078
    • Georgia
      • Columbus, Georgia, United States, 31909
        • Columbus Memory Center /ID# 249534
    • Idaho
      • Boise, Idaho, United States, 83704
        • Northwest Clinical Trials /ID# 248663
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Indiana University Health, Inc. /ID# 248300
      • Indianapolis, Indiana, United States, 46256
        • Josephson-Wallack-Munshower Neurology - Northeast /ID# 248554
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • University of Kentucky Sanders-Brown Center on Aging /ID# 251139
    • Louisiana
      • Alexandria, Louisiana, United States, 71301-3900
        • NeuroMedical Clinic of Central Louisiana /ID# 246960
      • Marrero, Louisiana, United States, 70072-3156
        • Tandem Clinical Research, LLC /ID# 246973
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Adams Clinical /ID# 248358
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Velocity Clinical Research, Inc /ID# 249837
    • Ohio
      • Beavercreek, Ohio, United States, 45432-2886
        • American Clinical Research Institute (ACRI) - Beavercreek /ID# 246930
      • Canton, Ohio, United States, 44718-2784
        • NeuroScience Research Center - Canton /ID# 248552
      • Dayton, Ohio, United States, 45459-4296
        • Neurology Diagnostics - South /ID# 246931
    • Oregon
      • Portland, Oregon, United States, 97210
        • Duplicate_Summit Headlands LLC /ID# 250678
    • Tennessee
      • Nashville, Tennessee, United States, 37232-0021
        • Vanderbilt Ingram Cancer Center /ID# 248801
    • Texas
      • Dallas, Texas, United States, 75231-4316
        • Kerwin Medical Center /ID# 248662
      • El Paso, Texas, United States, 79912
        • ANESC Research LLC /ID# 246958
      • Red Oak, Texas, United States, 75154-3981
        • Epic Medical Research /ID# 249141
    • Virginia
      • Norfolk, Virginia, United States, 23510-1065
        • Sentara Neurology Specialists - Norfolk /ID# 248578

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABBV-552: 1 mg
Participants will receive 1 mg of ABBV-552 once daily (QD) for 12 weeks.
Drug: ABBV-552
Oral Capsule
Experimental: ABBV-552: 5 mg
Participants will receive 5 mg of ABBV-552 QD for 12 weeks.
Drug: ABBV-552
Oral Capsule
Experimental: ABBV-552: 15 mg
Participants will receive 5 mg of ABBV-552 QD for 12 weeks.
Drug: ABBV-552
Oral Capsule
Placebo Comparator: Placebo
Participants will receive placebo for ABBV-552 QD for 12 weeks.
Drug: Placebo for ABBV-552
Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score at Week 12
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2023

Primary Completion (Actual)

August 6, 2024

Study Completion (Actual)

September 12, 2024

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M23-515
  • 2022-501918-55-00 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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