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Virus Therapy

SAD Cohort 2: ADEL Y-01 antibody at a dose of 7.5mg/Kg for Alzheimer's Disease

Phase 1

Recruiting

Research Sponsored by Alzheimer's Disease Expert Lab (ADEL), Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy male and/or female (of nonchildbearing potential) participants aged 18 to 65 years, inclusive

Meet specific criteria for MCI due to AD or Mild AD dementia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up d-28 ~ week 22

Awards & highlights

Study Summary

"This trial is testing a new drug called ADEL-Y01 in healthy participants and those with Alzheimer's disease. The study is divided into two parts, with the first part testing a single dose and the

Who is the study for?

This trial is for healthy adults aged 18-65 with a BMI of 18-30 kg/m2, who are not able to have children. Women must be postmenopausal or surgically sterile, and men must agree to use double contraception. Participants should be in good health as determined by the investigator and cannot drink alcohol before dosing.Check my eligibility

What is being tested?

ADEL-Y01 is being tested for safety and how it's processed in the body (pharmacokinetics) in healthy people first (Part 1), then in those with mild cognitive impairment (MCI) or mild Alzheimer's Disease (AD) later (Part 2). The study compares ADEL-Y01 against a placebo, given once initially then multiple times.See study design

What are the potential side effects?

Since this is an early-phase trial for ADEL-Y01, specific side effects aren't listed yet. Generally, participants may experience reactions related to drug administration which will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old and cannot become pregnant.

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I have been diagnosed with early-stage Alzheimer's disease.

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I weigh at least 50 kg and my BMI is between 18 and 35.

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I am between 50 and 80 years old with mild cognitive impairment due to Alzheimer's.

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I can walk on my own.

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My mental state score is between 21 and 27.

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I am using reliable birth control or am surgically sterile.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ d-28 ~ week 22

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~d-28 ~ week 22

This trial's timeline: 3 weeks for screening, Varies for treatment, and d-28 ~ week 22 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Evaluation of the safety and tolerability of ADEL-Y01 via single IV injection

Part 2: Assessment of safety and tolerability with multiple IV Administrations of ADEL-Y01 in participants with MCI due to AD or Mild AD

Secondary outcome measures

Part 1: Assessment of the exposure to ADEL-Y01 in CSF following a single IV injection

Part 1: Assessment of the immunogenicity of ADEL-Y01 following a single IV injection

Part 1: Characterization of the pharmacokinetics of ADEL-Y01 following a single IV injection

+4 more

Other outcome measures

Assessment of ADEL-Y01 Effects on Biomarkers in CSF and Plasma in Participants with MCI due to AD and Mild AD for Exploratory Objective

Trial Design

16Treatment groups

Active Control

Placebo Group

Group I: SAD Cohort 2: ADEL Y-01 antibody at a dose of 7.5mg/KgActive Control1 Intervention

This arm represents the group receiving ADEL Y-01 antibody at a dose of 7.5 mg/Kg in SAD cohort 2.

Group II: MAD Cohort 2: ADEL Y-01 antibody at a dose of 20mg/KgActive Control1 Intervention

This arm represents the group receiving ADEL Y-01 antibody at a dose of 20mg/Kg in MAD cohort 2.

Group III: MAD Cohort 3: ADEL Y-01 antibody at a dose of 50mg/KgActive Control1 Intervention

This arm represents the group receiving ADEL Y-01 antibody at a dose of 50mg/Kg in MAD cohort 3.

Group IV: SAD Cohort 1: ADEL Y-01 antibody at a dose of 2.5mg/KgActive Control1 Intervention

This arm represents the group receiving ADEL Y-01 antibody at a dose of 2.5mg/Kg in SAD cohort 1.

Group V: SAD Cohort 5: ADEL Y-01 antibody at a dose of 100mg/KgActive Control1 Intervention

This arm represents the group receiving ADEL Y-01 antibody at a dose of 100mg/Kg in SAD cohort 5.

Group VI: SAD Cohort 4: ADEL Y-01 antibody at a dose of 50mg/KgActive Control1 Intervention

This arm represents the group receiving ADEL Y-01 antibody at a dose of 50mg/Kg in SAD cohort 4.

Group VII: SAD Cohort 3: ADEL Y-01 antibody at a dose of 20mg/KgActive Control1 Intervention

This arm represents the group receiving ADEL Y-01 antibody at a dose of 20mg/Kg in SAD cohort 3.

Group VIII: MAD Cohort 1: ADEL Y-01 antibody at a dose of 7.5mg/KgActive Control1 Intervention

This arm represents the group receiving ADEL Y-01 antibody at a dose of 7.5 mg/Kg in MAD cohort 1.

Group IX: SAD Cohort 5: Placebo at a dose of 100mg/KgPlacebo Group1 Intervention

This arm represents the group receiving placebo at a dose of 100mg/Kg in SAD cohort 5.

Group X: MAD Cohort 3: Placebo at a dose of 50mg/KgPlacebo Group1 Intervention

This arm represents the group receiving placebo at a dose of 50mg/Kg in MAD cohort 3.

Group XI: MAD Cohort 1: Placebo at a dose of 7.5mg/KgPlacebo Group1 Intervention

This arm represents the group receiving placebo at a dose of 7.5mg/Kg in MAD cohort 1.

Group XII: SAD Cohort 1: Placebo at a dose of 2.5mg/KgPlacebo Group1 Intervention

This arm represents the group receiving placebo at a dose of 2.5mg/Kg in SAD cohort 1.

Group XIII: SAD Cohort 2: Placebo at a dose of 7.5mg/KgPlacebo Group1 Intervention

This arm represents the group receiving placebo at a dose of 7.5mg/Kg in SAD cohort 2.

Group XIV: SAD Cohort 3: Placebo at a dose of 20mg/KgPlacebo Group1 Intervention

This arm represents the group receiving placebo at a dose of 20mg/Kg in SAD cohort 3.

Group XV: MAD Cohort 2: Placebo at a dose of 20mg/KgPlacebo Group1 Intervention

This arm represents the group receiving placebo at a dose of 20mg/Kg in MAD cohort 2.

Group XVI: SAD Cohort 4: Placebo at a dose of 50mg/KgPlacebo Group1 Intervention

This arm represents the group receiving placebo at a dose of 50mg/Kg in SAD cohort 4.

0 / 7Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Oscotec Inc.Industry Sponsor

7 Previous Clinical Trials

339 Total Patients Enrolled

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

1 Previous Clinical Trials

7,000 Total Patients Enrolled

Seung-Yong YoonStudy ChairAlzheimer's Disease Expert Lab (ADEL), Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial open to individuals below 25 years of age?

"Eligible participants for this research must be between the ages of 18 and 80. It is noteworthy that there are a total of 14 investigations involving individuals younger than 18 years old, while there are 540 studies focusing on those over the age of 65."

Answered by AI

Which individuals meet the eligibility criteria for participation in this research endeavor?

"Individuals aged between 18 and 80 diagnosed with Alzheimer's disease are eligible to participate in this trial, which aims to recruit approximately 73 participants."

Answered by AI

What is the current number of participants under observation in this clinical investigation?

"Indeed, the information on clinicaltrials.gov reveals that this investigation is currently seeking eligible individuals. This study was initially uploaded on January 30th, 2024 and last modified on February 11th, 2024. The research aims to recruit a total of 73 participants at one designated site."

Answered by AI

Are there any available openings for participants in this ongoing trial?

"Indeed, as per clinicaltrials.gov data, this investigation is actively enrolling participants. The trial was first listed on January 30th, 2024 and last revised on February 11th of the same year. Researchers aim to recruit a total of 73 patients from a single site for this study."

Answered by AI

Has the FDA given its approval for SAD Cohort 1: ADEL Y-01 antibody at a dosage of 2.5mg/Kg?

"Based on our evaluation at Power, the safety rating for SAD Cohort 1: ADEL Y-01 antibody administered at a dosage of 2.5mg/Kg is marked as level 1. This assessment aligns with being in Phase I where data supporting both efficacy and safety are constrained."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06247345.

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