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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: Completed Phase 2 study, sponsored by AbbVie.
NCT05771428 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 263 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 \
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 |
What the finished NCT05771428 record still lists
NCT05771428 is an interventional study that assigns participants to a tested intervention. The registered 263 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 2 interventions - of which ABBV-552 is the first listed.
NCT05771428 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05771428's enrollment target sits among peer trials
263 210th of 2000 higher than 1,791 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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