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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: Recruiting Phase 1 study of Alzheimer Disease, sponsored by Alzheimer's Disease Expert Lab (ADEL).
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. According to ClinicalTrials.gov, the official US trial registry.
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 \[MAD\]).
Primary Outcome
The standard safety and tolerability parameters to be assessed in the study include, but are not limited to, the following: Adverse Events (AEs) Vital signs, including blood pressure, pulse rate, pulse oximetry, respiratory rate, and body temperature Digital 12-lead ECGs Clinical laboratory assessments, encompassing hematology, biochemistry, coagulation, and urinalysis Physical examinations, which will include neurological assessments.
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 |
What NCT06247345 shows while recruiting
NCT06247345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (97% lower).
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 lists 6 locations in 4 states (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.
Learn More About Clinical Trials
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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 NCT06247345's enrollment target sits among peer trials
73 175th of 306 higher than 132 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease 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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