ADEL-Y01 for Alzheimer's Disease
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Alzheimer's Disease Expert Lab (ADEL), Inc.
Must be taking: Cholinesterase inhibitors, Memantine
Must not be taking: Antipsychotics, Narcotics
Disqualifiers: Cancer, Renal failure, Infections, others
Trial Summary
What is the purpose of this trial?
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 \[MAD\]).
Will I have to stop taking my current medications?
For Part 1, participants must stop taking most medications, including over-the-counter ones, 14 days before the study. For Part 2, participants can continue their Alzheimer's medications if they have been on a stable dose for 3 months before the study.
What safety data exists for ADEL-Y01 (Aducanumab) in humans?
Aducanumab, also known as Aduhelm, has been studied for Alzheimer's disease and received FDA approval in 2021. The most significant safety concern noted in trials is amyloid-related imaging abnormalities, which are changes seen in brain scans. Long-term safety is still being evaluated in ongoing studies.12345
How does the drug ADEL-Y01 differ from other Alzheimer's treatments?
Research Team
SY
Seung-Yong Yoon
Principal Investigator
Alzheimer's Disease Expert Lab (ADEL), Inc.
Eligibility Criteria
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.Inclusion Criteria
Must have a positive amyloid positron emission tomography (within 12 months prior to screening) or CSF Abeta (42/40) ratio consistent with AD pathology
I am between 18 and 65 years old and cannot become pregnant.
I am a male willing to use condoms and spermicide for 3 months after treatment.
See 27 more
Exclusion Criteria
I am a male unwilling to use two forms of birth control.
Ingestion of poppy seeds within 24 hours prior to each Drug Abuse Screening
Abnormal vital signs, abnormal ECG findings, or prolonged QTcF
See 16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
Treatment Part 1 (SAD)
Single ascending dose administration of ADEL-Y01 or placebo to healthy participants
12 weeks
8 visits (in-person)
Treatment Part 2 (MAD)
Multiple ascending dose administration of ADEL-Y01 or placebo to participants with MCI due to AD or mild AD
22 weeks
12 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- ADEL-Y01 (Virus Therapy)
Trial OverviewADEL-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.
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Innovation Medical ResearchPalmetto Bay, FL
Accel Research - NeurostudiesDecatur, GA
Quest Research InstituteFarmington Hills, MI
CenExel ACTAnaheim, CA
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Who Is Running the Clinical Trial?
Alzheimer's Disease Expert Lab (ADEL), Inc.
Lead Sponsor
Trials
2
Patients Recruited
7,100+
Oscotec Inc.
Industry Sponsor
Trials
8
Patients Recruited
430+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Aducanumab: First Approval.Dhillon, S.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
ACU193: An Immunotherapeutic Poised to Test the Amyloid β Oligomer Hypothesis of Alzheimer's Disease.Krafft, GA., Jerecic, J., Siemers, E., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The "rights" of precision drug development for Alzheimer's disease.Cummings, J., Feldman, HH., Scheltens, P.[2023]
Aducanumab is a monoclonal antibody that targets aggregated amyloid β (Aβ) in Alzheimer's disease, showing an objective reduction in Aβ levels but conflicting results regarding its clinical efficacy in improving symptoms.
The most significant safety concern associated with aducanumab treatment is the occurrence of amyloid-related imaging abnormalities, which raises questions about its overall risk-benefit profile despite its recent accelerated approval by the FDA for mild Alzheimer's disease.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Aducanumab for the treatment of Alzheimer's disease.Tagliapietra, M.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Lessons from antiamyloid-β immunotherapies in Alzheimer's disease.Plascencia-Villa, G., Perry, G.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Prevalence of neuropsychiatric symptoms in young-onset compared to late-onset Alzheimer's disease - part 1: findings of the two-year longitudinal NeedYD-study.van Vliet, D., de Vugt, ME., Aalten, P., et al.[2013]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Peripheral Blood and Cerebrospinal Fluid Levels of YKL-40 in Alzheimer's Disease: A Systematic Review and Meta-Analysis.Zhang, Y., Tian, J., Ni, J., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Astrocyte-specific knockout of YKL-40/Chi3l1 reduces Aβ burden and restores memory functions in 5xFAD mice.Zeng, X., Cheung, SKK., Shi, M., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Clinical issues of younger patients with dementia--Japan Psychogeriatric Society].Arai, H.[2011]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Structural Brain Changes in Early-Onset Alzheimer's Disease Subjects Using the LONI Pipeline Environment.Moon, SW., Dinov, ID., Hobel, S., et al.[2018]
References
Aducanumab: First Approval. [2021]
ACU193: An Immunotherapeutic Poised to Test the Amyloid β Oligomer Hypothesis of Alzheimer's Disease. [2022]
The "rights" of precision drug development for Alzheimer's disease. [2023]
Aducanumab for the treatment of Alzheimer's disease. [2022]
Lessons from antiamyloid-β immunotherapies in Alzheimer's disease. [2023]
Prevalence of neuropsychiatric symptoms in young-onset compared to late-onset Alzheimer's disease - part 1: findings of the two-year longitudinal NeedYD-study. [2013]
Peripheral Blood and Cerebrospinal Fluid Levels of YKL-40 in Alzheimer's Disease: A Systematic Review and Meta-Analysis. [2023]
Astrocyte-specific knockout of YKL-40/Chi3l1 reduces Aβ burden and restores memory functions in 5xFAD mice. [2023]
[Clinical issues of younger patients with dementia--Japan Psychogeriatric Society]. [2011]
Structural Brain Changes in Early-Onset Alzheimer's Disease Subjects Using the LONI Pipeline Environment. [2018]