A Study to Assess Safety of ABBV-916 and How Intravenous ABBV-916 Moves Through Body and Affects Brain Amyloid Plaque Clearance in Adult Participants (Aged 50-90 Years) With Early Alzheimer's Disease

• Status: Not yet recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: All

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-916 is in treating early AD. Adverse events, change in disease activity and how ABBV-916 moves through body of participants will be assessed.

ABBV-916 is an investigational drug being developed for the treatment of AD. This study is conducted in 2 stages. Stage A is a dose-ascending study. There is 1 in 4 chance that participants are assigned to receive placebo. Stage B is dose-expansion conducted in 2 dose cohorts and there is 1 in 6 chance that participants are assigned to receive placebo. Additional cohorts may be added to Stage B. This study is "open-label", which means that both the trial participants and the study doctors know which treatments will be given. Approximately 288 participants aged 50-90 years will be enrolled in approximately 200 sites across the world.

Participants will receive intravenous (IV) doses of ABBV-916 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for an additional 16 weeks.

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, magnetic resonance imaging (MRI), blood tests, checking for side effects and completing questionnaires.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie

Criteria

Inclusion Criteria:

• Diagnosis of Stage 3 or Stage 4 Alzheimer's disease (AD) based on the 2018 National Institute on Aging (NIA)-Alzheimer's Association (AA) Research Framework Criteria.

• Mini-Mental State Examination (MMSE) score of 20 to 28, inclusive, at Screening.

• Plasma Aβ42/Aβ40 value consistent with increased likelihood of positive amyloid positron emission tomography (PET).

• Amyloid PET scan results consistent with amyloid pathology.

• Stage B: Participants must have a study partner who spends a minimum average of 10 hours per week with the participant.

Exclusion Criteria:

• Clinically significant and/or unstable medical conditions or any other reason that the Investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive ABBV-916.

• Screening magnetic resonance imaging (MRI) show evidence of intracranial hemorrhage, cerebrovascular aneurysm, arteriovenous malformation, carotid artery occlusion, stroke, or significant abnormality.

• Significant pathological findings on brain MRI at screening including, but not limited to, evidence of vasogenic edema, 4 or more microhemorrhages, any macrohemorrhages, superficial siderosis, or severe white matter disease.