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NCT05771428 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 2
- Development phase
- 263
- Enrollment target
NCT05771428 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 263 participants.
The verdict
NCT05771428, a Phase 2 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 263 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-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.
Interventions
- DRUG ABBV-552
- DRUG Placebo for ABBV-552
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 263 participants |
| Start Date | 2023-06-05 |
| Est. Completion | 2024-09-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05771428
The ClinicalTrials.gov registry entry for NCT05771428 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 263 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 ABBV-552 is the first listed.
NCT05771428 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05771428 about?
NCT05771428 is a clinical study titled "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". 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 NCT05771428?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 263 participants. The study started on 2023-06-05. Estimated completion is 2024-09-12.
What interventions are being tested in trial NCT05771428?
The interventions under investigation include: ABBV-552 (DRUG), Placebo for ABBV-552 (DRUG).
Who is sponsoring clinical trial NCT05771428?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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