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

NCT05834296 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ALZN002-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• TEAEs

  Frequency and severity of TEAEs

  Through study completion, up to 33 months

Secondary Outcomes (13)

• SAEs

  Through study completion, up to 33 months

• Study Completion

  Through study completion, up to 33 months

• Number of Participants with changes from baseline in safety laboratory values.

  Through study completion, up to 33 months

• Number of Participants with changes from baseline in blood pressure.

  Through study completion, up to 33 months

• Number of Participants with changes from baseline in heart rate.

  Through study completion, up to 33 months

Study Arms (2)

Active

EXPERIMENTAL

ALZN002 (autologous DCs pulsed with E22W mutant peptide).

Biological: ALZN002 (autologous DCs pulsed with E22W mutant peptide).

Placebo

PLACEBO COMPARATOR

Saline ID and IV administrations.

Drug: Placebo

Interventions

ALZN002 (autologous DCs pulsed with E22W mutant peptide). BIOLOGICAL

The cellular immunotherapy product consists of autologous dendritic cells (DCs) pulsed with a novel amyloid-beta peptide (Aβ1 42) containing a mutation at position 22 from glutamic acid to tryptophan (E22W). This mutation produces novel CD4+ T cell epitopes specific for the mutant E22W peptide that can facilitate an anti-Aβ1-42 antibody response. The activated E22W peptide specific CD4+ T cells license Aβ1-42-specific B cells to secrete anti Aβ1-42 antibodies, resulting in systemic reduction of amyloid and reduction or slowed accumulation of amyloid plaques in the brain.

Active

Placebo DRUG

Saline

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential study subjects must satisfy the following criteria to be randomized in the study:
• Age ≥60 and ≤85 years with no restrictions on gender, race, or ethnicity.
• Able and willing to give informed consent and adhere to study requirements, including testing for cognitive and functional abilities.
• there should be no clinically significant change in the subject's symptoms and cognitive abilities within the 6 months prior to Screening.
• The quality and accuracy of the historical positive amyloid PET needs to be confirmed by the central imaging center
• Willing and able to have amyloid PET taken at Screening (if no historical adequate amyloid PET within 6 months of Screening is available) to confirm AD and at Week 31 and Week 143 as a potential efficacy measure.
• Willing and able to have magnetic resonance imaging (MRI) taken at Screening, at 1 year (Week 55) and 2 years (Week 101) after the 3rd dose, and at 1 year after the 10th dose (Week 143/EOS) as potential safety measures.
• Males (non-vasectomized and vasectomized) must agree to use barrier contraception during the study until 30 days after the last dose of the study investigational treatment.
• Females must meet one the of the following criteria:
• a. Either is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:
• i. Abstinence from heterosexual intercourse from the Screening visit through to at least 30 days after the last dose of the study investigational treatment
• ii. One of the following highly-effective contraceptive methods, used from at least 28 days prior to the Screening visit through to at least 30 days after the last dose of the study investigational treatment:
• Systemic contraceptive (combined birth control pills, injectable/implant/insertable hormonal birth control products, or transdermal patch)
• Intrauterine device (with or without hormones)
• Male condom used with male partner vasectomized at least 6 months prior to the Screening visit

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from participating in the study:
• Prior immunotherapies and specifically therapies that may elicit T cell or antibody responses to Aβ, whether investigational or approved by the FDA, for AD or other conditions.
• Delirium, non-AD dementia or cognitive impairment, or other encephalopathies.
• Subjects with major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder, or has current alcohol or substance abuse based on psychiatric consultation at Screening visit.
• Neuropsychiatric Inventory (NPI-Q) total score ≥14 or score ≥4 in any NPI domain (clinically significant neuropsychiatric symptoms). Apathy score ≥4 acceptable.
• At risk for suicide in the opinion of the investigator or the subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) (at the time of evaluation) at the screening visit or attempted suicide within the last 2 years.
• Modified Hachinski Scale10 score \>4 or evidence of stroke within the past 5 years.
• History of moderate or more severe traumatic brain injury in the 2 years prior to signing the consent to participate in the study.
• History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on MRI.
• History of seizure disorder.
• Contraindications for PET scanning or any protocol testing procedure.
• Known autoimmune disease (properly treated hypothyroidism and stable rheumatoid arthritis allowed), biomarkers exceeding 1:80 for antinuclear antibodies, 20 IU/mL (or 1:80) for rheumatic factor, 26 AU/mL for antineutrophil cytoplasmic antibodies; or history of allergic reaction to any related product of infused cells.
• Current malignancy, with the exception of non-invasive (stage 0 or stage 1) basal and squamous cell carcinoma with planned excision. Subjects with a prior successfully treated malignancy and a sufficient follow-up to exclude the likelihood of recurrence may be enrolled at the discretion of the Principal Investigator.
• History of or current HIV, HBV, or HCV (unless subjects who test positive for hepatitis C antibody are in remission with sustained virologic response, as evidenced by undetectable HCV RNA level using a sensitive assay ≥12 weeks after completion of HCV therapy).
• Elevated C-reactive protein (\>5.0 mg/L) using a high sensitivity test.

Sponsors & Collaborators

• Alzamend Neuro, Inc.: lead
• bioRASI, LLC: collaborator

Study Sites (1)

First Excellent Research Group

Doral, Florida, 33186, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each cohort will have 10 total subjects randomized in a 7:3 ratio (active:placebo). Subjects will be randomly allocated to treatment groups based on a central computer-generated randomization scheme.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: April 28, 2023
• Study Start: July 5, 2023
• Primary Completion (Estimated): March 3, 2028
• Study Completion (Estimated): March 3, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)