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Cancer Vaccine
ALZN002 for Alzheimer's Disease
Phase 1 & 2
Waitlist Available
Research Sponsored by Alzamend Neuro, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 33 months
Awards & highlights
Study Summary
This trial studies a new drug to treat Alzheimer's in people with mild-moderate dementia.
Who is the study for?
This trial is for individuals aged 60-85 with mild-to-moderate Alzheimer's dementia, who can consent and adhere to study requirements. They must have a confirmed diagnosis of Alzheimer's via PET scan, be willing to undergo further PET scans and MRIs, use contraception if necessary, and have a reliable study partner. Excluded are those with prior immunotherapies for Alzheimer's or other conditions, non-Alzheimer’s dementia or cognitive impairments, major psychiatric disorders, autoimmune diseases, current malignancy or infectious diseases.Check my eligibility
What is being tested?
The ALZN002-01 trial tests the safety and effectiveness of ALZN002 (a personalized cell therapy using one’s own immune cells modified with an amyloid beta mutant peptide) against placebo in people with mild-to-moderate Alzheimer’s dementia. Participants will be randomly assigned to receive either the experimental treatment or placebo in a double-blind setup where neither they nor the researchers know who gets what.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions related to immune system activation since ALZN002 involves dendritic cells (immune cells). There could also be risks associated with leukapheresis (a procedure to collect white blood cells), PET scans, MRI procedures as well as general discomfort from injections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 33 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 33 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
TEAEs
Secondary outcome measures
Anti-Aβ1-42 antibody titer
DTH Response
Infusion Reactions
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
ALZN002 (autologous DCs pulsed with E22W mutant peptide).
Group II: PlaceboPlacebo Group1 Intervention
Saline ID and IV administrations.
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Who is running the clinical trial?
bioRASI, LLCIndustry Sponsor
13 Previous Clinical Trials
3,372 Total Patients Enrolled
Alzamend Neuro, Inc.Lead Sponsor
1 Previous Clinical Trials
65 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to undergo MRI scans at specified times after my treatment doses.I agree to use barrier contraception during and up to 30 days after the study.I am willing and able to undergo a procedure to collect white blood cells.My symptoms and thinking abilities have been stable for the last 6 months.My Alzheimer's diagnosis was confirmed with a positive amyloid PET scan.I am willing and able to follow the study's requirements and consent to tests on my thinking and physical abilities.I am between 60 and 85 years old.I have previously received immunotherapies targeting Aβ.I am not taking medications that could affect my thinking or blood clotting.I agree to have genetic testing and RNA analysis.I am either not able to have children or I am following specific birth control guidelines.I have been diagnosed with Alzheimer's disease by a qualified doctor.I don't have autoimmune diseases, other cancers, or issues with PET scans.I am willing to undergo PET scans to confirm Alzheimer's at the start, Week 31, and Week 143.I do not have major psychiatric disorders, dementia (other than Alzheimer's), or a history of stroke.I have been diagnosed with mild to moderate dementia.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Active
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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