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NCT03635047 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study for Safety and Tolerability of AL002.
A Phase 1 study of Healthy and Alzheimer Disease, sponsored by Alector.
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
- 6
- Study locations
NCT03635047: Completed Phase 1 study of Healthy and Alzheimer Disease, sponsored by Alector.
NCT03635047 is a Phase 1 study of Healthy and Alzheimer Disease that has completed, run by Alector. The registered enrollment target is 69 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03635047, a Phase 1 study of Healthy and Alzheimer Disease, has completed, sponsored by Alector.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a multi-centre, randomized, double-blind, placebo-controlled, dose escalation first in human (FIH) study in healthy adults and in patients with mild to moderate Alzheimer's disease. The study is designed to systematically assess the safety (including immunogenicity) and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AL002.
Primary Outcome
Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
Conditions Studied
Interventions
- OTHER Saline Solution
- BIOLOGICAL AL002
Study Locations (6)
Florida
- Brain Matters Research - Delray Beach
- Compass Research - Orlando - Orlando
- Compass Research - The Villages - The Villages
Other
- Nucleus Network Pty Ltd - Melbourne
- University College London - London
New York
- Columbia University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2018-11-12 |
| Est. Completion | 2020-11-25 |
| Phase | Phase 1 |
What the finished NCT03635047 record still lists
NCT03635047 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Saline Solution is the first listed.
NCT03635047 lists 6 locations in 3 states (Florida, Other, New York).
Frequently Asked Questions
What is clinical trial NCT03635047 about?
NCT03635047 is a clinical study titled "A Phase I Study for Safety and Tolerability of AL002.". This is a multi-centre, randomized, double-blind, placebo-controlled, dose escalation first in human (FIH) study in healthy adults and in patients with mild to moderate Alzheimer's disease. The study is designed to systematically assess the safety (including immunogenicity) and tolerability, pharmac...
What is the current status of trial NCT03635047?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2018-11-12. Estimated completion is 2020-11-25.
What conditions does trial NCT03635047 study?
This clinical trial studies the following conditions: Healthy, Alzheimer Disease.
What interventions are being tested in trial NCT03635047?
The interventions under investigation include: Saline Solution (OTHER), AL002 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03635047?
This trial is sponsored by Alector, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03635047 being conducted?
This trial has 6 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03635047's enrollment target sits among peer trials
69 333rd of 1090 higher than 757 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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