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Alzheimer's Disease (AD)Phase 2AbroadNCT05771428

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

A Phase 2 study testing ABBV-552 in people with Alzheimer's Disease (AD), run by AbbVie at 64 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer's Disease (AD)
What is being tested?
ABBV-552
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
263 participants
Where
64 sitesin 7 countries
Study dates
5 Jun 2023to 12 Sep 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

64 sites in 7 countries.

64 sites in 7 countries

United States37 sites

  • NeuroMedical Clinic of Central Louisiana /ID# 246960

    Alexandria, Louisiana, 71301-3900

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

    Beavercreek, Ohio, 45432-2886

  • Northwest Clinical Trials /ID# 248663

    Boise, Idaho, 83704

  • NeuroScience Research Center - Canton /ID# 248552

    Canton, Ohio, 44718-2784

  • Vertex Research Group Inc /ID# 248295

    Clermont, Florida, 34711-5037

  • Columbus Memory Center /ID# 249534

    Columbus, Georgia, 31909

  • Kerwin Medical Center /ID# 248662

    Dallas, Texas, 75231-4316

  • Neurology Diagnostics - South /ID# 246931

    Dayton, Ohio, 45459-4296

  • ANESC Research LLC /ID# 246958

    El Paso, Texas, 79912

  • Indiana University Health, Inc. /ID# 248300

    Fort Wayne, Indiana, 46804

  • Finlay Medical Research - West Palm Beach /ID# 246970

    Greenacres City, Florida, 33467-2979

  • Velocity Clinical Research - Hallandale Beach /ID# 246896

    Hallandale, Florida, 33009-4427

  • New Life Medical Research Center - Hialeah /ID# 247536

    Hialeah, Florida, 33012

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

    Indianapolis, Indiana, 46256

  • Irvine Clinical Research /ID# 250030

    Irvine, California, 92614

  • K2 Medical Research - The Villages /ID# 250820

    Lady Lake, Florida, 32159-8975

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

    Lexington, Kentucky, 40504

  • Alliance for Research Alliance for Wellness /ID# 246492

    Long Beach, California, 90807

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

    Los Alamitos, California, 90720

  • Tandem Clinical Research, LLC /ID# 246973

    Marrero, Louisiana, 70072-3156

  • Allied Biomedical Res Inst Inc /ID# 246971

    Miami, Florida, 33155

  • Ivetmar Medical Group, LLC. /ID# 247670

    Miami, Florida, 33155

  • New Horizon Research Center /ID# 248298

    Miami, Florida, 33165-3372

  • Vanderbilt Ingram Cancer Center /ID# 248801

    Nashville, Tennessee, 37232-0021

  • Sentara Neurology Specialists - Norfolk /ID# 248578

    Norfolk, Virginia, 23510-1065

  • K2 Medical Research - Ocoee /ID# 251029

    Ocoee, Florida, 34761-4547

  • Health Synergy Clinical Research LLC /ID# 247726

    Okeechobee, Florida, 34972-2568

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

    Orlando, Florida, 32751

  • Combined Research Orlando Phase I-IV /ID# 247697

    Orlando, Florida, 32814

  • Duplicate_Summit Headlands LLC /ID# 250678

    Portland, Oregon, 97210

  • Velocity Clinical Research, Inc /ID# 249837

    Raleigh, North Carolina, 27607

  • Epic Medical Research /ID# 249141

    Red Oak, Texas, 75154-3981

  • New England Institute for Clinical Research /ID# 246488

    Stamford, Connecticut, 06905

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

    Stuart, Florida, 34997-5765

  • Adams Clinical /ID# 248358

    Watertown, Massachusetts, 02472

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

    Wellington, Florida, 33414

  • Conquest Research /ID# 262078

    Winter Park, Florida, 32789

Other trials in United States

Japan9 sites

  • Juntendo University Hospital /ID# 252373

    Bunkyo-ku, Tokyo, 113-8431

  • Duplicate_Kawashima Neurology Clinic /ID# 253561

    Fujisawa-shi, Kanagawa, 251-0038

  • Shonan Kamakura General Hospital /ID# 256664

    Kamakura-shi, Kanagawa, 247-8533

  • Hizen Psychiatric Center /ID# 252363

    Kanzaki-gun, Saga-ken, 842-0192

  • Nara Medical University Hospital /ID# 252564

    Kashihara-shi, Nara, 634-8522

  • NHO Niigata National Hospital /ID# 254207

    Kashiwazaki-shi, Niigata, 945-8585

  • Teikyo University Mizonokuchi Hospital /ID# 253259

    Kawasaki, Kanagawa, 213-8507

  • NHO Hiroshima-Nishi Medical center /ID# 256947

    Otake-shi, Hiroshima, 739-0696

  • Oita University Hospital /ID# 253679

    Yufu, Oita Prefecture, 879-5503

Other trials in Japan

Spain6 sites

  • Hospital Internacional Ruber - Grupo Quiron Salud /ID# 248856

    Madrid, 28034

  • Clinica Universidad de Navarra - Pamplona /ID# 248415

    Pamplona, Navarre, 31008

  • Hospital Universitario de Salamanca /ID# 249101

    Salamanca, 37711

  • Hospital Universitari General de Catalunya /ID# 249100

    Sant Cugat del Vallès, Barcelona, 08195

  • Hospital Universitario Marques de Valdecilla /ID# 248454

    Santander, Cantabria, 39008

  • Hospital Universitari Mútua Terrassa /ID# 248448

    Terrassa, Barcelona, 08221

Other trials in Spain

United Kingdom5 sites

  • Re:Cognition Health Birmingham /ID# 249796

    Birmingham, B16 8LT

  • Re:Cognition Health Bristol /ID# 249795

    Bristol, BS32 4SY

  • St Pancras Clinical Research /ID# 249006

    London, EC2Y 8EA

  • Re:Cognition Health - London /ID# 249005

    London, W1G 9JF

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

    Motherwell, Lanarkshire, ML3 4UF

Other trials in United Kingdom

Australia4 sites

  • Box Hill Hospital /ID# 249095

    Box Hill, Victoria, 3128

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

    Darlinghurst, New South Wales, 2010

  • Southern Neurology - Kogarah /ID# 249098

    Kogarah, New South Wales, 2217

  • Australian Alzheimer's Res Fou /ID# 249097

    Nedlands, Western Australia, 6009

Other trials in Australia

Germany2 sites

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 248078

    Berlin, 12203

  • Universitaetsklinikum des Saarlandes /ID# 248077

    Homburg, Saarland, 66424

Other trials in Germany

New Zealand1 site

  • CGM Research Trust /ID# 249439

    Christchurch Central, 8011

Other trials in New Zealand

About this study

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

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.

Read more

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.

Being tested
ABBV-552, Placebo for ABBV-552
Keywords
Alzheimer's disease (AD), Dementia, ABBV-552
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-552Drug

    Oral Capsule

  • Placebo for ABBV-552Drug

    Oral Capsule

Study groups in NCT05771428
Study groupRoleWhat they receive
ABBV-552: 1 mgExperimentalParticipants will receive 1 mg of ABBV-552 once daily (QD) for 12 weeks.
Receives: Drug: ABBV-552
ABBV-552: 5 mgExperimentalParticipants will receive 5 mg of ABBV-552 QD for 12 weeks.
Receives: Drug: ABBV-552
ABBV-552: 15 mgExperimentalParticipants will receive 5 mg of ABBV-552 QD for 12 weeks.
Receives: Drug: ABBV-552
PlaceboPlacebo comparatorParticipants will receive placebo for ABBV-552 QD for 12 weeks.
Receives: Drug: Placebo for ABBV-552

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start5 Jun 2023
  3. Primary completion6 Aug 2024
  4. Study completion12 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05771428
Sponsor's protocol ID
M23-515
Other IDs
2022-501918-55-00
Acronym
Abroad
Status last verified
Sep 2025
First submitted
6 Mar 2023
Last updated
15 Oct 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-552 in people with Alzheimer's Disease (AD), run by AbbVie at 64 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Japan, Spain, United Kingdom, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05771428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.

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