ALZN002 for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Alzamend Neuro, Inc.

Trial Summary

What is the purpose of this trial?ALZN002-01 is a first-in-human, randomized, double-blind, placebo-controlled, parallel-group, phase 1/2a study of autologous amyloid beta mutant peptide-pulsed dendritic cells (ALZN002) in subjects with mild-to-moderate dementia of the Alzheimer's type.

Eligibility Criteria

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.

Inclusion 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.

+13 more

Exclusion Criteria

Positive urine drug screen for controlled substances, alcohol abuse, or any condition that may unfavorably alter the risk-benefit of subject participation

I have previously received immunotherapies targeting Aβ.

I am not taking medications that could affect my thinking or blood clotting.

+5 more

Participant Groups

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.

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.