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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
263
Oral Capsule
Oral Capsule
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
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.
Time frame: Week 12
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Finlay Medical Research - West Palm Beach /ID# 246970
Greenacres City, Florida, United States
Velocity Clinical Research - Hallandale Beach /ID# 246896
Hallandale, 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
...and 54 more locations