Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01
NCT06247345 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alzheimer's Disease Expert Lab (ADEL), which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06247345 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
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. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.