ALZN002 for Alzheimer's Disease

Overseen By Donald P Reitberg, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Alzamend Neuro, Inc.

Must not be taking: Anticholinergics, Antidepressants, Antipsychotics, others

Disqualifiers: Schizophrenia, Bipolar, Stroke, others

Compensation: Varies

Number of Visits: Unknown

Duration: 21 months

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but certain medications are restricted. You must have a stable dose of cholinesterase inhibitors or memantine for at least 60 days before the trial and maintain it during the study. Some medications like certain blood thinners and sleep aids are allowed under specific conditions.

Is ALZN002 safe for humans?

Alzhemed (also known as tramiprosate), which may be related to ALZN002, was found to be safe and well tolerated in a study with Alzheimer's patients. It was tested over a long period (up to 36 months) and showed no significant safety concerns. ^{1 2 3 4 5}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending doses of ALZN002 or placebo to assess safety and tolerability

21 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• ALZN002

Trial Overview 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.

Participant Groups

Group I: Active Experimental Treatment 1 Intervention

ALZN002 (autologous DCs pulsed with E22W mutant peptide).

Group II: Placebo Placebo Group 1 Intervention

Saline ID and IV administrations.

Who Is Running the Clinical Trial?

Alzamend Neuro, Inc.

Lead Sponsor

Trials

2

Recruited

100+

bioRASI, LLC

Industry Sponsor

Trials

14

Recruited

3,400+

Findings from Research

In a study involving 144 subjects with amnestic mild cognitive impairment, AL-108 was found to be generally safe and well tolerated over 12 weeks of treatment.

While the overall efficacy analysis did not show a significant difference in cognitive memory scores between AL-108 and placebo, there were promising signals of potential efficacy in specific memory and attention tasks, suggesting further research is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled, ascending-dose, randomized study to evaluate the safety, tolerability and effects on cognition of AL-108 after 12 weeks of intranasal administration in subjects with mild cognitive impairment. Morimoto, BH., Schmechel, D., Hirman, J., et al.[2016]

Alzhemed (tramiprosate) is a well-tolerated treatment for mild-to-moderate Alzheimer's disease that effectively reduces levels of the neurotoxic amyloid-beta peptide in the cerebrospinal fluid after 3 months of treatment.

While Alzhemed did not show immediate cognitive improvements after 3 months, long-term follow-up suggested stabilization of cognitive function, particularly in patients with mild Alzheimer's disease, indicating potential benefits over extended use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alzhemed: a potential treatment for Alzheimer's disease. Aisen, PS., Gauthier, S., Vellas, B., et al.[2019]

In a review of safety data from five 18-month Alzheimer's disease trials, common adverse events included dyspnea (5.3%-5.8%), headache (4.0%-5.5%), and constipation (4.3%-4.7%), indicating a consistent profile of side effects among patients taking placebo.

Larger multinational studies showed higher overall discontinuation rates (24.6%-33.0%) compared to smaller studies (8.2%-21.0%), suggesting that study size and geography may influence patient retention and safety outcomes in Alzheimer's trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of Alzheimer's disease populations in Alzheimer's Disease Neuroimaging Initiative and other 18-month studies. Henley, DB., Sundell, KL., Sethuraman, G., et al.[2021]

In an 11-week study involving 181 patients with mild to moderate Alzheimer's disease, the alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid modulator LY451395 did not show significant improvement in cognitive function compared to placebo, as measured by the ADAS-Cog scale.

While there were some marginal improvements in neuropsychiatric symptoms after 8 weeks of treatment, the overall safety profile was similar between LY451395 and placebo, with most adverse events being mild.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AMPA potentiator treatment of cognitive deficits in Alzheimer disease. Chappell, AS., Gonzales, C., Williams, J., et al.[2022]

Akatinol memantine significantly improved cognitive function, behavior, and mood in patients with mild to moderate Alzheimer's disease, showing similar efficacy to donepezil over a 16-week treatment period with 100 participants.

The treatment was found to be safe, with only mild and transient adverse events reported in 6% of patients, indicating that akatinol memantine is a viable option for managing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical efficacy and safety of akatinol memantine in treatment of mild to moderate Alzheimer disease: a donepezil-controlled, randomized trial]. Hu, HT., Zhang, ZX., Yao, JL., et al.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled, ascending-dose, randomized study to evaluate the safety, tolerability and effects on cognition of AL-108 after 12 weeks of intranasal administration in subjects with mild cognitive impairment. [2016]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Alzhemed: a potential treatment for Alzheimer's disease. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Safety profile of Alzheimer's disease populations in Alzheimer's Disease Neuroimaging Initiative and other 18-month studies. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

AMPA potentiator treatment of cognitive deficits in Alzheimer disease. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Clinical efficacy and safety of akatinol memantine in treatment of mild to moderate Alzheimer disease: a donepezil-controlled, randomized trial]. [2018]