DUVAX Vaccine for Alzheimer's Disease

(DU-PRISM Trial)

Not yet recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Nuravax, Inc.

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Psychiatric illness, MRI abnormalities, others

Compensation: Varies

Number of Visits: 28

Duration: 22 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine called DUVAX to determine its safety and ability to help the body produce antibodies against proteins linked to Alzheimer's disease. Participants will receive injections of either the DUVAX vaccine at varying doses or a placebo (a harmless substance resembling the vaccine) for comparison. The main goal is to assess vaccine tolerance and whether it triggers an immune response. Healthy adults with no significant health issues and within a specific weight range may be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use immunosuppressive agents or chronic anticoagulants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that similar vaccines targeting amyloid-beta, like Nuravax, have been safe in early trials and have triggered a good immune response. DUVAX is currently in the early stages of testing, so researchers are still determining its safety for people. This phase focuses on ensuring the treatment does not cause serious side effects. As a new vaccine, DUVAX hasn't been tested for age-related conditions other than Alzheimer's. Currently, specific data on DUVAX's safety in humans is unavailable. However, researchers are closely monitoring its effects to ensure it is well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about DUVAX because it represents a novel approach to treating Alzheimer's disease. Unlike current treatments, which typically focus on managing symptoms or slowing disease progression, DUVAX is designed as a vaccine that aims to stimulate the body's immune response against the disease itself. The treatment involves intramuscular injections of either 200 µg or 400 µg of DUVAX formulated with an adjuvant, which is meant to enhance the immune reaction. This mechanism of action is quite different from existing Alzheimer's medications, which primarily target neurotransmitter activity. If successful, DUVAX could offer a proactive way to combat Alzheimer's, potentially altering the disease course rather than just managing symptoms.

What evidence suggests that the DUVAX vaccine might be an effective treatment for Alzheimer's?

Research shows that the DUVAX vaccine, which participants in this trial may receive, is designed to help the body produce antibodies against proteins linked to Alzheimer's disease. The vaccine targets two specific proteins, Aβ and tau, believed to contribute to the disease's progression. In animal studies, similar vaccines successfully triggered immune responses against these proteins. Early results suggest this method might help reduce the build-up of these proteins, potentially slowing the disease's progress. However, limited information from human studies exists, and more research is needed to determine its effectiveness in people. ^{1 2 3 6 7}

Who Is on the Research Team?

Anahit Ghochikyan, PhD

Principal Investigator

IMM

David Cribbs, PhD

Principal Investigator

Nuravax, Inc.

Roman Kniazev

Principal Investigator

Nuravax, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults who are at risk of developing Alzheimer's disease but currently show no symptoms. Participants should not have any history of severe allergic reactions to vaccines or ingredients in DUVAX.

Inclusion Criteria

Signed informed consent

I am a man who is either vasectomized or agrees to use condoms and not donate sperm during the study.

I am not pregnant and use birth control.

Exclusion Criteria

MRI abnormalities (e.g., infarcts, microbleeds, ARIA-E) or contraindications to MRI

I am currently taking medication that affects my immune system or blood clotting.

I do not have any major health or mental issues that could affect my safety or the study's outcomes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three intramuscular injections of DUVAX or placebo at Weeks 0, 4, and 22

22 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Visits at Weeks 25, 38, and 74

What Are the Treatments Tested in This Trial?

Interventions

• DUVAX

Trial Overview The study tests the safety and immune response to DUVAX, a vaccine aimed at preventing Alzheimer's. Participants will receive either the vaccine at two different doses (200 µg or 400 µg) or a placebo via injection, randomly assigned.

How Is the Trial Designed?

Group I: Active - DUVAX 400 µg Experimental Treatment 1 Intervention

Participants receive three intramuscular injections of DUVAX 400 µg formulated with Adjuvant at Weeks 0, 4, and 22.

Group II: Active - DUVAX 200 µg Experimental Treatment 1 Intervention

Participants receive three intramuscular injections of DUVAX 200 µg formulated with Adjuvant at Weeks 0, 4, and 22.

Group III: Placebo (Adjuvant only) Placebo Group 1 Intervention

Participants receive three intramuscular injections of placebo (adjuvant formulation without active antigen) at Weeks 0, 4, and 22.

Who Is Running the Clinical Trial?

Nuravax, Inc.

Lead Sponsor

Trials

1

Recruited

20+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Institute for Molecular Medicine

Collaborator

Trials

7

Recruited

3,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07142278

DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting ... The study will evaluate how well the vaccine is tolerated and whether it produces antibodies against Alzheimer's disease-related proteins.

2. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Duvax_%28drug_in_development%29.pdf

1 Last updated on February 18, 2025 Cognitive Vitality ... Aging and related health concerns: No studies have tested Duvax for age-related conditions aside from Alzheimer's disease. Safety: In mice, AV-1959R/D and ...

3. reporter.nih.gov reporter.nih.gov/search/9nkGKCcfMU6kNtd3zfRVxg/project-details/11067040

Project Details Project Narrative Phase 1 (R43) of this project aims to assess the overall safety and determine the optimal dose range of the Duvax vaccine targeting Aβ/tau in ...

4. clival.com clival.com/news/nuravax-imm-to-present-alzheimers-vaccine-data-at-ctad-2025

Nuravax & IMM to Present Alzheimer's Vaccine Data at ... "Nuravax, Institute for Molecular Medicine to present phase 1 results & phase 2 design of Alzheimer's vaccine AV-1959R at CTAD 2025.

5. withpower.com withpower.com/trial/phase-1-alzheimer-disease-10-2025-631a4

DUVAX Vaccine for Alzheimer's Disease · Info for Participants The study will evaluate how well the vaccine is tolerated and whether it produces antibodies against Alzheimer's disease-related proteins.

6. insideprecisionmedicine.com insideprecisionmedicine.com/topics/precision-medicine/nuravax-alzheimers-vaccine-to-amyloid-beta-is-safe-immunogenic-in-phase-1/

Nuravax Alzheimer's Vaccine to Amyloid-Beta Is Safe, ... Nuravax's Alzheimer's disease mRNA vaccine AV-1959R for amyloid beta recently passed its first clinical milestone: the vaccine was deemed safe and triggered ...

7. prnewswire.com prnewswire.com/news-releases/breakthrough-alzheimers-vaccine-duvax-secures-3-million-nih-grant-to-launch-us-clinical-trials-302446078.html

Breakthrough Alzheimer's Vaccine Duvax Secures $3 ... The grant, awarded through NIH's highly competitive SBIR Fast-Track program, will fund a critical milestone in the clinical validation of Duvax.