A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease
Start Date
5/15/2026
Completion Date
10/1/2030
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. The purpose of this study is to test how safe ABBV-1758 is, how well it works, how the body processes it and what effects it has on the body. ABBV-1758 is an investigational drug being developed for the treatment of Alzheimer's disease. This study is conducted in 3 stages. Stage A is a multiple ascending dose study with a 1 in 5 chance (4:1 randomization) that participants are assigned to receive placebo. Stage B is a dose expansion phase, also using 4:1 randomization for ABBV-1758 or placebo. Stage C enrolls Japanese and Chinese participants with the same randomization scheme. Approximately 210 participants will be enrolled at about 55 sites in the United States, China, and Japan. Participants will receive intravenous (IV) or subcutaneous (SC) doses of ABBV-1758 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for additional 12 weeks in the Follow-up Period. Participants will have the option of participating in a 12-month, blinded Extension Period receiving ABBV-1758 or placebo based on amyloid PET results. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The safety of the treatment will be checked by medical assessments, blood tests, and completing questionnaires.
Eligibility Criteria
Age Range: 50 years to 90 years
Interventions
ABBV-1758
Placebo for ABBV-1758
ABBV-1758
Placebo for ABBV-1758
Conditions
Locations
Irvine Center for Clinical Research /ID# 277752
Irvine, California 92614
United States
Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856
Boulder, Colorado 80301
United States
Key Clinical Research LLC /ID# 277800
Bradenton, Florida 34207
United States
K2 Medical Research - Clermont /ID# 277859
Clermont, Florida 34711
United States
K2 Medical Research - The Villages /ID# 278290
Lady Lake, Florida 32159
United States
Alzheimer'S Research And Treatment Center - Stuart /ID# 278206
Stuart, Florida 34997
United States
Alzheimer's Research And Treatment Center - Wellington /ID# 277749
Wellington, Florida 33414
United States
Conquest Research - Winter Park /ID# 277760
Winter Park, Florida 32789
United States
Adams Clinical /ID# 277754
Watertown, Massachusetts 02472
United States
Neurology Clinic - Cordova /ID# 277790
Cordova, Tennessee 38018
United States
Kerwin Medical Center /ID# 277788
Dallas, Texas 75231
United States