RECRUITING

A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 \[MAD\]).

Official Title

First in Human, Phase Ia/Ib Study for Safety, Tolerability, Pharmacokinetics, and Clinical Activity Evaluation of ADEL-Y01 in Healthy Participants and in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

Quick Facts

Study Start:2024-02-06
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06247345

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Yuna Oh
CONTACT
82-10-6645-0316
ynoh@adelpharm.com
Minseok Kim
CONTACT
82-10-9129-3618
mskim@adelpharm.com

Principal Investigator

Seung-Yong Yoon
STUDY_CHAIR
Alzheimer's Disease Expert Lab (ADEL), Inc.

Study Locations (Sites)

CenExel ACT
Anaheim, California, 92801
United States

Collaborators and Investigators

Sponsor: Alzheimer's Disease Expert Lab (ADEL), Inc.

  • Seung-Yong Yoon, STUDY_CHAIR, Alzheimer's Disease Expert Lab (ADEL), Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-06
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2024-02-06
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

  • Alzheimer Disease
  • Dementia
  • Cognitive Dysfunction
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Tauopathies
  • Neurodegenerative Diseases
  • Neurocognitive Disorders
  • Mental Disorders
  • Cognition Disorders
  • Tau MTBR
  • Disease Modifying Treatments
  • Monoclonal antibodies (mAbs)

Additional Relevant MeSH Terms

  • Alzheimer Disease