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
- Conditions
- Alzheimer's Disease (AD)
- Interventions
- Drug: Placebo for ABBV-552
- Registration Number
- NCT05771428
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABBV-552 Dose C ABBV-552 Participants will receive ABBV-552 Dose C QD for 12 weeks. Placebo for ABBV-552 Placebo for ABBV-552 Participants will receive placebo for ABBV-552 QD for 12 weeks. ABBV-552 Dose A ABBV-552 Participants will receive ABBV-552 Dose A once daily (QD) for 12 weeks. ABBV-552 Dose B ABBV-552 Participants will receive ABBV-552 Dose B QD for 12 weeks.
- Primary Outcome Measures
Name Time Method Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) score From Baseline (Week 0) through 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (64)
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 Beach, 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 /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
Neurology Diagnostics - South /ID# 246931
🇺🇸Dayton, Ohio, 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
Allied Physicians - Fort Wayne Neurological Center /ID# 248300
🇺🇸Fort Wayne, Indiana, United States
Josephson-Wallack-Munshower Neurology - Northeast /ID# 248554
🇺🇸Indianapolis, Indiana, United States
University of Kentucky HealthCare - Turfland /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
Hospital Universitario de Salamanca /ID# 249101
🇪🇸Salamanca, Spain
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
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 248078
🇩🇪Berlin, Germany
Universitaetsklinikum des Saarlandes /ID# 248077
🇩🇪Homburg, Germany
NHO Hiroshima-Nishi Medical center /ID# 256947
🇯🇵Otake-shi, Hiroshima, Japan
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 City, Oita, Japan
Hizen Psychiatric Center /ID# 252363
🇯🇵Kanzaki-gun, Saga, Japan
Juntendo University Hospital /ID# 252373
🇯🇵Bunkyo-ku, Tokyo, Japan
CGM Research Trust /ID# 249439
🇳🇿Christchurch, 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, Navarra, Spain
Hospital Internacional Ruber - Grupo Quiron Salud /ID# 248856
🇪🇸Madrid, Spain
Re:Cognition Health Bristol /ID# 249795
🇬🇧Bristol, Bristol, City Of, United Kingdom
Re:Cognition Health Birmingham /ID# 249796
🇬🇧Birmingham, United Kingdom
St Pancras Clinical Research /ID# 249006
🇬🇧London, United Kingdom
Re:Cognition Health - London /ID# 249005
🇬🇧London, United Kingdom
NeuroClin Limited(Previously Glasgow Memory Clinic) /ID# 249787
🇬🇧Motherwell, United Kingdom