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NCT05291234 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
NCT05291234 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 106 participants.
The verdict
NCT05291234, a Phase 2 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
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-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 early AD. This study is conducted in 2 stages. Stage A is a multiple ascending dose study. There is a 1 in 4 chance that participants are assigned to receive placebo. Stage B is a proof-of-concept study. In Stage B, there is a 1 in 5 chance that participants will be assigned to receive placebo. The first 6 months of this study are "double-blind," which means that neither the trial participant nor the study doctors know which treatments will be given. This will be followed by a 2-year extension period in which all participants will receive ABBV-916. Approximately 195 participants aged 50-90 years will be enrolled in about 90 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. Participants will have the option of participating in a 2-year, open-label, Extension Period receiving IV ABBV-916. 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.
Interventions
- DRUG Placebo
- DRUG ABBV-916
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2022-08-15 |
| Est. Completion | 2025-11-19 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05291234
The ClinicalTrials.gov registry entry for NCT05291234 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05291234 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05291234 about?
NCT05291234 is a clinical study titled "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". 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 prog...
What is the current status of trial NCT05291234?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2022-08-15. Estimated completion is 2025-11-19.
What interventions are being tested in trial NCT05291234?
The interventions under investigation include: Placebo (DRUG), ABBV-916 (DRUG).
Who is sponsoring clinical trial NCT05291234?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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