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NCT06247345 · ClinicalTrials.gov registry record · Phase 1
A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01
A Phase 1 study of Alzheimer Disease, sponsored by Alzheimer's Disease Expert Lab (ADEL).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
- 6
- Study locations
NCT06247345 is a Phase 1 study of Alzheimer Disease that is actively recruiting participants, run by Alzheimer's Disease Expert Lab (ADEL). The registered enrollment target is 73 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 4 states.
The verdict
NCT06247345, a Phase 1 study of Alzheimer Disease, is actively recruiting participants, sponsored by Alzheimer's Disease Expert Lab (ADEL).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a Phase Ia/Ib, two-part, randomized, placebo-controlled, double-blinded, first in human(FIH) study to evaluate the safety, tolerability, PK, and PD of ADEL-Y01 in healthy participants in Part 1 and participants with MCI due to AD and mild AD in Part 2. The study includes 2 parts: Part 1 (single ascending dose \[SAD\] and Part 2 (multiple ascending dose \[MAD\]).
Conditions Studied
Interventions
- DRUG ADEL-Y01 - healty participants
- DRUG Placebo - Healthy Participants
- DRUG ADEL-Y01 - MCI/AD
- DRUG Placebo - MCI/AD
Study Locations (6)
Florida
- K2 Medical Research - The Villages - Lady Lake
- K2 Medical Research - Orlando - Maitland
- Innovation Medical Research - Palmetto Bay
California
- CenExel ACT - Anaheim
Georgia
- Accel Research - Neurostudies - Decatur
Michigan
- Quest Research Institute - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2024-02-06 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06247345
The ClinicalTrials.gov registry entry for NCT06247345 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (97% lower). The listed sponsor is Alzheimer's Disease Expert Lab (ADEL), which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 4 interventions - of which ADEL-Y01 - healty participants is the first listed.
NCT06247345 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06247345 about?
NCT06247345 is a clinical study titled "A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01". This is a Phase Ia/Ib, two-part, randomized, placebo-controlled, double-blinded, first in human(FIH) study to evaluate the safety, tolerability, PK, and PD of ADEL-Y01 in healthy participants in Part 1 and participants with MCI due to AD and mild AD in Part 2. The study includes 2 parts: Part 1 (sin...
What is the current status of trial NCT06247345?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2024-02-06. Estimated completion is 2027-07-31.
What conditions does trial NCT06247345 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT06247345?
The interventions under investigation include: ADEL-Y01 - healty participants (DRUG), Placebo - Healthy Participants (DRUG), ADEL-Y01 - MCI/AD (DRUG), Placebo - MCI/AD (DRUG).
Who is sponsoring clinical trial NCT06247345?
This trial is sponsored by Alzheimer's Disease Expert Lab (ADEL), which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06247345 being conducted?
This trial has 6 study locations across California, Florida, Georgia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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