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Cancer Vaccine

ALZN002 for Alzheimer's Disease

Phase 1 & 2

Recruiting

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 33 months for reporting.

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 more

Trial 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

bioRASI, LLCIndustry Sponsor

13 Previous Clinical Trials

3,626 Total Patients Enrolled

Alzamend Neuro, Inc.Lead Sponsor

1 Previous Clinical Trials

65 Total Patients Enrolled

Media Library

ALZN002 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05834296 — Phase 1 & 2

Alzheimer's Disease Research Study Groups: Placebo, Active

Alzheimer's Disease Clinical Trial 2023: ALZN002 Highlights & Side Effects. Trial Name: NCT05834296 — Phase 1 & 2

ALZN002 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05834296 — Phase 1 & 2

Frequently Asked Questions

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

Is there an age restriction for enrolment in this clinical research?

"This clinical trial is seeking patients aged between 60 and 85 years old. However, there are 22 studies available for minors and 740 more suited to seniors."

Answered by AI

Is this research endeavor currently open to participants?

"Data hosted on clinicaltrials.gov affirms that this medical trial, which was originally posted on July 5th 2023, is recruiting participants. The most recent edits to the study were made on July 28th 2023."

Answered by AI

How many individuals are currently engaged in this clinical experiment?

"Yes, according to clinicaltrials.gov this study is actively enrolling patients. It was first posted on the 5th of July 2023 and updated most recently on the 28th of July 2023. The trial requires 30 individuals from a single medical centre."

Answered by AI

Is it possible for me to become involved in this experiment?

"This clinical trial is in search of 30 volunteers between the ages of 60 and 85, all diagnosed with Alzheimer's disease. To meet the criteria for inclusion, participants must provide informed consent, have an amyloid PET scan taken within 6 months prior to screening or during screening if no historical data is available, a MRI at Screening and 1 year after the 3rd dose as well as 2 years after said dose and again one year following the 10th dose., Males (vasectomized or not) are required to use barrier contraception from their initial visit until one month past last medication administration date while females can either opt-in for abstinence"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study in Subjects With Mild-to-Moderate Alzheimer's Dementia

2023. "Study in Subjects With Mild-to-Moderate Alzheimer's Dementia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05834296.

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