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

Last updated: September 26, 2025
Sponsor: AbbVie
Overall Status: Completed

Phase

2

Condition

Dementia

Treatment

ABBV-552

Placebo for ABBV-552

Clinical Study ID

NCT05771428
M23-515
2022-501918-55-00
  • Ages 50-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's disease according to the National Institute ofAging-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 atleast 1 CDR functional domain (community affairs, home and hobbies, or personalcare) score of 0.5 or higher at Screening Visit 1.

Exclusion

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 Design

Total Participants: 263
Treatment Group(s): 2
Primary Treatment: ABBV-552
Phase: 2
Study Start date:
June 05, 2023
Estimated Completion Date:
September 12, 2024

Connect with a study center

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

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Southern Neurology - Kogarah /ID# 249098

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Southern Neurology /ID# 249098

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

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

    Darlinghurst 2169378, New South Wales 2155400 2010
    Australia

    Site Not Available

  • Southern Neurology - Kogarah /ID# 249098

    Kogarah 2161185, New South Wales 2155400 2217
    Australia

    Site Not Available

  • Box Hill Hospital /ID# 249095

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Box Hill Hospital /ID# 249095

    Box Hill 2174360, Victoria 2145234 3128
    Australia

    Site Not Available

  • Australian Alzheimer's Res Fou /ID# 249097

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Australian Alzheimer's Res Fou /ID# 249097

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • Universitaetsklinikum Frankfurt /ID# 248076

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • St. Josef-Hospital /ID# 248636

    Bochum, Nordrhein-Westfalen 44791
    Germany

    Site Not Available

  • Universitaetsklinikum des Saarlandes /ID# 248077

    Homburg 2899449, Saarland 2842635 66424
    Germany

    Site Not Available

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

    Berlin, 12203
    Germany

    Site Not Available

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

    Berlin 2950159, 12203
    Germany

    Site Not Available

  • Universitaetsklinikum des Saarlandes /ID# 248077

    Homburg, 66424
    Germany

    Site Not Available

  • NHO Hiroshima-Nishi Medical center /ID# 256947

    Otake-shi, Hiroshima 1862413 739-0696
    Japan

    Site Not Available

  • Kawashima Neurology Clinic /ID# 253561

    Fujisawa-shi, Kanagawa 251-0038
    Japan

    Site Not Available

  • Teikyo University Mizonokuchi Hospital /ID# 253259

    Kawasaki, Kanagawa 213-8507
    Japan

    Site Not Available

  • Teikyo University Hospital, Mizonokuchi /ID# 253259

    Kawasaki-shi, Kanagawa 213-8507
    Japan

    Site Not Available

  • Duplicate_Kawashima Neurology Clinic /ID# 253561

    Fujisawa-shi, Kanagawa 1860291 251-0038
    Japan

    Site Not Available

  • Shonan Kamakura General Hospital /ID# 256664

    Kamakura-shi, Kanagawa 1860291 247-8533
    Japan

    Site Not Available

  • Teikyo University Mizonokuchi Hospital /ID# 253259

    Kawasaki 1859642, Kanagawa 1860291 213-8507
    Japan

    Site Not Available

  • Nara Medical University Hospital /ID# 252564

    Kashihara-shi, Nara 634-8522
    Japan

    Site Not Available

  • Nara Medical University Hospital /ID# 252564

    Kashihara-shi 1859951, Nara 1855608 634-8522
    Japan

    Site Not Available

  • NHO Niigata National Hospital /ID# 254207

    Kashiwazaki-shi, Niigata 1855429 945-8585
    Japan

    Site Not Available

  • Oita University Hospital /ID# 253679

    Yufu City, Oita 879-5503
    Japan

    Site Not Available

  • Oita University Hospital (MRI) /ID# 253679

    Yufu-shi, Oita 879-5593
    Japan

    Site Not Available

  • Oita University Hospital /ID# 253679

    Yufu-shi, Oita 879-5593
    Japan

    Active - Recruiting

  • Oita University Hospital /ID# 253679

    由布市, Oita 〒879-5503
    Japan

    Site Not Available

  • Oita University Hospital /ID# 253679

    Yufu 11612342, Oita Prefecture 1854484 879-5503
    Japan

    Site Not Available

  • Hizen Psychiatric Center /ID# 252363

    Kanzaki-gun, Saga-ken 1853299 842-0192
    Japan

    Site Not Available

  • Kanto Central Hospital of the Mutual Aid Association of Public School Teachers /ID# 252321

    Setagaya-ku, Tokyo 158-8531
    Japan

    Site Not Available

  • Juntendo University Hospital /ID# 252373

    Bunkyo-ku, Tokyo 1850144 113-8431
    Japan

    Site Not Available

  • CGM Research Trust /ID# 249439

    Christchurch, 8011
    New Zealand

    Site Not Available

  • CGM Research Trust /ID# 249439

    Christchurch Central, 8011
    New Zealand

    Site Not Available

  • Hospital Universitari General de Catalunya /ID# 249100

    Sant Cugat del Vallès, Barcelona 08195
    Spain

    Site Not Available

  • Hospital Universitari General de Catalunya /ID# 249100

    Sant Cugat del Vallès 3110718, Barcelona 08195
    Spain

    Site Not Available

  • Hospital Universitario Mutua Terrassa /ID# 248448

    Terrasa, Barcelona 08221
    Spain

    Site Not Available

  • Hospital Universitari Mútua Terrassa /ID# 248448

    Terrassa, Barcelona 08221
    Spain

    Site Not Available

  • Hospital Universitari Mútua Terrassa /ID# 248448

    Terrassa 3108286, Barcelona 08221
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla /ID# 248454

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Unversitario Marques de Valdecilla /ID# 248454

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Universitario Marques de Valdecilla /ID# 248454

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Site Not Available

  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 248415

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Pamplona /ID# 248415

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clinica Universidad de Navarra - Pamplona /ID# 248415

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Site Not Available

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 251017

    Madrid, 28027
    Spain

    Site Not Available

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

    Madrid, 28034
    Spain

    Site Not Available

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

    Madrid 3117735, 28034
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca /ID# 249101

    Salamanca, 37711
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca /ID# 249101

    Salamanca 6544491, 37711
    Spain

    Site Not Available

  • Re:Cognition Health Bristol /ID# 249795

    Bristol, Bristol, City Of BS32 4SY
    United Kingdom

    Site Not Available

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

    Motherwell 2642135, Lanarkshire ML3 4UF
    United Kingdom

    Site Not Available

  • Re:Cognition Health Birmingham /ID# 249796

    Birmingham, B16 8LT
    United Kingdom

    Site Not Available

  • Re:Cognition Health Birmingham /ID# 249796

    Birmingham 2655603, B16 8LT
    United Kingdom

    Site Not Available

  • Re:Cognition Health Bristol /ID# 249795

    Bristol 2654675, BS32 4SY
    United Kingdom

    Site Not Available

  • Re:Cognition Health - London /ID# 249005

    London, W1G 9JF
    United Kingdom

    Site Not Available

  • St Pancras Clinical Research /ID# 249006

    London, EC2Y 8EA
    United Kingdom

    Site Not Available

  • Re:Cognition Health - London /ID# 249005

    London 2643743, W1G 9JF
    United Kingdom

    Site Not Available

  • St Pancras Clinical Research /ID# 249006

    London 2643743, EC2Y 8EA
    United Kingdom

    Site Not Available

  • Glasgow Memory Clinic /ID# 249787

    Motherwell, ML3 4UF
    United Kingdom

    Site Not Available

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

    Motherwell, ML3 4UF
    United Kingdom

    Site Not Available

  • Irvine Clinical Research /ID# 250030

    Irvine, California 92614
    United States

    Site Not Available

  • Alliance for Research - Long Beach /ID# 246492

    Long Beach, California 90807
    United States

    Active - Recruiting

  • Alliance for Research Alliance for Wellness /ID# 246492

    Long Beach, California 90807
    United States

    Site Not Available

  • Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 248891

    Los Alamitos, California 90720-3500
    United States

    Active - Recruiting

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

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Artemis Institute for Clinical Research - Riverside /ID# 250677

    Riverside, California 92503-7123
    United States

    Site Not Available

  • Irvine Clinical Research /ID# 250030

    Irvine 5359777, California 5332921 92614
    United States

    Site Not Available

  • Alliance for Research Alliance for Wellness /ID# 246492

    Long Beach 5367929, California 5332921 90807
    United States

    Site Not Available

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

    Los Alamitos 5368304, California 5332921 90720
    United States

    Site Not Available

  • New England Institute for Clinical Research /ID# 246488

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • New England Institute for Clinical Research /ID# 246488

    Stamford 4843564, Connecticut 4831725 06905
    United States

    Site Not Available

  • Vertex Research Group Inc /ID# 248295

    Clermont, Florida 34711-5037
    United States

    Site Not Available

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

    Greenacres City, Florida 33467-2979
    United States

    Site Not Available

  • Velocity Clinical Research - Hallandale Beach /ID# 246896

    Hallandale Beach, Florida 33009-4427
    United States

    Site Not Available

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

    Hialeah, Florida 33012
    United States

    Site Not Available

  • New Life Medical Research Center /ID# 247536

    Hialeah, Florida 33012-4654
    United States

    Active - Recruiting

  • K2 Medical Research - The Villages /ID# 250820

    Lady Lake, Florida 32159-8975
    United States

    Site Not Available

  • K2 Summit Research /ID# 250820

    Lady Lake, Florida 32159-8975
    United States

    Site Not Available

  • K2 Medical Research /ID# 250904

    Maitland, Florida 32751-5669
    United States

    Site Not Available

  • Allied Biomedical Res Inst Inc /ID# 246971

    Miami, Florida 33155
    United States

    Site Not Available

  • Ivetmar Medical Group /ID# 247670

    Miami, Florida 33155
    United States

    Site Not Available

  • Ivetmar Medical Group LLC /ID# 247670

    Miami, Florida 33155-6542
    United States

    Active - Recruiting

  • New Horizon Research Center /ID# 248298

    Miami, Florida 33165-3372
    United States

    Site Not Available

  • K2 Medical Research - Ocoee /ID# 251029

    Ocoee, Florida 34761-4547
    United States

    Site Not Available

  • Health Synergy Clinical Research LLC /ID# 247726

    Okeechobee, Florida 34972-2568
    United States

    Site Not Available

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

    Orlando, Florida 32807
    United States

    Active - Recruiting

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

    Orlando, Florida 32814
    United States

    Site Not Available

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

    Orlando, Florida 32751
    United States

    Site Not Available

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

    Stuart, Florida 34997-5765
    United States

    Site Not Available

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

    Wellington, Florida 33414
    United States

    Site Not Available

  • Conquest Research /ID# 262078

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Vertex Research Group Inc /ID# 248295

    Clermont 4151352, Florida 4155751 34711-5037
    United States

    Site Not Available

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

    Greenacres City 4157467, Florida 4155751 33467-2979
    United States

    Site Not Available

  • Velocity Clinical Research - Hallandale Beach /ID# 246896

    Hallandale 4157898, Florida 4155751 33009-4427
    United States

    Site Not Available

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

    Hialeah 4158476, Florida 4155751 33012
    United States

    Site Not Available

  • K2 Medical Research - The Villages /ID# 250820

    Lady Lake 4161118, Florida 4155751 32159-8975
    United States

    Site Not Available

  • Allied Biomedical Res Inst Inc /ID# 246971

    Miami 4164138, Florida 4155751 33155
    United States

    Site Not Available

  • Ivetmar Medical Group, LLC. /ID# 247670

    Miami 4164138, Florida 4155751 33155
    United States

    Site Not Available

  • New Horizon Research Center /ID# 248298

    Miami 4164138, Florida 4155751 33165-3372
    United States

    Site Not Available

  • K2 Medical Research - Ocoee /ID# 251029

    Ocoee 4166776, Florida 4155751 34761-4547
    United States

    Site Not Available

  • Health Synergy Clinical Research LLC /ID# 247726

    Okeechobee 4166822, Florida 4155751 34972-2568
    United States

    Site Not Available

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

    Orlando 4167147, Florida 4155751 32814
    United States

    Site Not Available

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

    Orlando 4167147, Florida 4155751 32751
    United States

    Site Not Available

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

    Stuart 4174201, Florida 4155751 34997-5765
    United States

    Site Not Available

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

    Wellington 4177703, Florida 4155751 33414
    United States

    Site Not Available

  • Conquest Research /ID# 262078

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Columbus Memory Center /ID# 249534

    Columbus, Georgia 31909
    United States

    Site Not Available

  • Columbus Memory Center /ID# 249534

    Columbus 4188985, Georgia 4197000 31909
    United States

    Site Not Available

  • Northwest Clinical Trials /ID# 248663

    Boise, Idaho 83704
    United States

    Site Not Available

  • Northwest Clinical Trials /ID# 248663

    Boise 5586437, Idaho 5596512 83704
    United States

    Site Not Available

  • Allied Physicians - Fort Wayne Neurological Center /ID# 248300

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

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

    Indianapolis, Indiana 46256-4692
    United States

    Site Not Available

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

    Indianapolis, Indiana 46256
    United States

    Site Not Available

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

    Indianapolis, Indiana 46256-4692
    United States

    Active - Recruiting

  • Indiana University Health, Inc. /ID# 248300

    Fort Wayne 4920423, Indiana 4921868 46804
    United States

    Site Not Available

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

    Indianapolis 4259418, Indiana 4921868 46256
    United States

    Site Not Available

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

    Lexington, Kentucky 40504-3504
    United States

    Active - Recruiting

  • University of Kentucky Chandler Medical Center /ID# 251139

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • University of Kentucky HealthCare - Turfland /ID# 251139

    Lexington, Kentucky 40504
    United States

    Site Not Available

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

    Lexington 4297983, Kentucky 6254925 40504
    United States

    Site Not Available

  • NeuroMedical Clinic of Central Louisiana /ID# 246960

    Alexandria, Louisiana 71301-3900
    United States

    Site Not Available

  • Tandem Clinical Research, LLC /ID# 246973

    Marrero, Louisiana 70072-3156
    United States

    Site Not Available

  • NeuroMedical Clinic of Central Louisiana /ID# 246960

    Alexandria 4314550, Louisiana 4331987 71301-3900
    United States

    Site Not Available

  • Tandem Clinical Research, LLC /ID# 246973

    Marrero 4332628, Louisiana 4331987 70072-3156
    United States

    Site Not Available

  • Adams Clinical /ID# 248358

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • Adams Clinical /ID# 248358

    Watertown 4954611, Massachusetts 6254926 02472
    United States

    Site Not Available

  • Raleigh Neurology Associates /ID# 249837

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Velocity Clinical Research, Inc /ID# 249837

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Velocity Clinical Research, Inc /ID# 249837

    Raleigh 4487042, North Carolina 4482348 27607
    United States

    Site Not Available

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

    Beavercreek, Ohio 45432-2886
    United States

    Site Not Available

  • NeuroScience Research Center - Canton /ID# 248552

    Canton, Ohio 44718-2784
    United States

    Site Not Available

  • Neurology Diagnostics - South /ID# 246931

    Dayton, Ohio 45459-4296
    United States

    Site Not Available

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

    Beavercreek 4506008, Ohio 5165418 45432-2886
    United States

    Site Not Available

  • NeuroScience Research Center - Canton /ID# 248552

    Canton 5149222, Ohio 5165418 44718-2784
    United States

    Site Not Available

  • Neurology Diagnostics - South /ID# 246931

    Dayton 4509884, Ohio 5165418 45459-4296
    United States

    Site Not Available

  • Summit Headlands LLC /ID# 250678

    Portland, Oregon 97210
    United States

    Site Not Available

  • Summit Research Network /ID# 250678

    Portland, Oregon 97210
    United States

    Site Not Available

  • Duplicate_Summit Headlands LLC /ID# 250678

    Portland 5746545, Oregon 5744337 97210
    United States

    Site Not Available

  • Vanderbilt Ingram Cancer Center /ID# 248801

    Nashville, Tennessee 37232-0021
    United States

    Site Not Available

  • Vanderbilt Ingram Cancer Center /ID# 248801

    Nashville 4644585, Tennessee 4662168 37232-0021
    United States

    Site Not Available

  • Kerwin Medical Center /ID# 248662

    Dallas, Texas 75231-4316
    United States

    Site Not Available

  • Kerwin Research Center /ID# 248662

    Dallas, Texas 75231-4316
    United States

    Site Not Available

  • ANESC Research /ID# 246958

    El Paso, Texas 79912-1786
    United States

    Active - Recruiting

  • ANESC Research LLC /ID# 246958

    El Paso, Texas 79912
    United States

    Site Not Available

  • Advanced Neuro Research Centers (ANRC) /ID# 246958

    El Paso, Texas 79912-1786
    United States

    Active - Recruiting

  • Epic Medical Research /ID# 249141

    Red Oak, Texas 75154-3981
    United States

    Site Not Available

  • Kerwin Medical Center /ID# 248662

    Dallas 4684888, Texas 4736286 75231-4316
    United States

    Site Not Available

  • ANESC Research LLC /ID# 246958

    El Paso 5520993, Texas 4736286 79912
    United States

    Site Not Available

  • Epic Medical Research /ID# 249141

    Red Oak 4721921, Texas 4736286 75154-3981
    United States

    Site Not Available

  • Sentara Neurology Specialists - Norfolk /ID# 248578

    Norfolk, Virginia 23510-1065
    United States

    Site Not Available

  • Sentara Neurology Specialists - Norfolk /ID# 248578

    Norfolk 4776222, Virginia 6254928 23510-1065
    United States

    Site Not Available

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