AV-1980R Vaccine for Alzheimer's Disease

(TAURUS-1980 Trial)

Overseen By Roman Kniazev

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: Institute for Molecular Medicine

Must not be taking: Immunosuppressives, Anticoagulants

Disqualifiers: Cardiovascular, Endocrine, Neurological, others

Compensation: Varies

Number of Visits: 6

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, AV-1980R, to determine its safety and effect on the immune system in individuals with early signs of Alzheimer's disease. The goal is to assess whether the vaccine can potentially slow the disease before symptoms appear. Participants will receive varying doses of the vaccine or a placebo (a substance with no active drug) to compare results. This trial is ideal for adults aged 65-80 who do not have cognitive impairments but have markers suggesting early Alzheimer’s. 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 have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it mentions that your medications should be stable. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that the AV-1980R vaccine is likely to be safe for humans?

Research has shown that AV-1980R, a vaccine targeting the tau protein in Alzheimer's, is currently undergoing safety testing in humans. Animal studies found the vaccine highly effective at triggering an immune response, indicating potential effectiveness.

Since AV-1980R is in Phase 1 trials, the focus is on safety and tolerability. At this stage, researchers test the treatment in small groups to assess safety and monitor for side effects. This phase is crucial to ensure the treatment does not cause significant harm before further testing.

Although specific safety data for humans is not yet available, reaching this stage suggests that earlier results were promising enough to proceed. Researchers will closely monitor for any side effects throughout the trial, as with any new treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Unlike the standard Alzheimer's treatments, which mainly focus on managing symptoms, the AV-1980R vaccine offers a novel approach by aiming to target the underlying disease process. Researchers are excited about AV-1980R because it is designed to stimulate the immune system to attack and clear abnormal protein deposits in the brain, which are thought to contribute to Alzheimer's. This vaccine is administered intramuscularly at specific intervals, potentially offering a more proactive and long-term strategy to combat the progression of Alzheimer's disease.

What evidence suggests that the AV-1980R vaccine might be an effective treatment for Alzheimer's disease?

Research shows that the AV-1980R vaccine targets a protein called tau, linked to Alzheimer's disease. Previous studies found that this vaccine can help the immune system produce antibodies against tau, potentially combating brain changes leading to Alzheimer's. Early results suggest the vaccine is safe and might slow the disease if administered early. The vaccine uses a technology called MultiTEP, which has previously shown promise in boosting immune responses. While these findings are hopeful, more research is needed to confirm its effectiveness. Participants in this trial will receive different dosages of the AV-1980R vaccine or a placebo to further evaluate its safety and effectiveness. ^{1 2 3 5 6}

Who Is on the Research Team?

Michael Agadjanyan, PhD

Principal Investigator

Institute MM

Roman Kniazev

Principal Investigator

Institute MM

Are You a Good Fit for This Trial?

This trial is for cognitively unimpaired adults aged 65-80 who show early signs of Alzheimer's disease through biomarkers but do not yet have symptoms. Specific details about inclusion and exclusion criteria are not provided, but typically these would relate to overall health, other medications being taken, and possibly lifestyle factors.

Inclusion Criteria

Cognitively unimpaired with preclinical Alzheimer's disease: CDR global score = 0, MMSE ≥ 26, WMS-R LM II ≥ 6, Amyloid Probability Score 2 (APS2) > 54 (PrecivityAD2™), Adequate vision/hearing to comply with study procedures, Stable concomitant medications if applicable, Signed informed consent

I am a man or a woman who cannot have children, aged 65-80.

Exclusion Criteria

MRI abnormalities: >1 large lacunar infarct, territorial infarct, >5 microbleeds, ARIA-E, or other significant pathology

Contraindications to MRI (e.g., pacemaker, metallic implants, severe claustrophobia)

Insulin-dependent diabetes, significant arrhythmias, or seizure disorder, Positive C-SSRS (score ≥ 3), Prior tau or amyloid-beta immunotherapy within 1 year, Immunosuppressive or anticoagulant use that could interfere with study safety, Clinically significant lab abnormalities or positive HIV, HBV, or HCV screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AV-1980R or placebo intramuscularly at Weeks 0, 4, 12, and 36

36 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AV-1980R

Trial Overview The trial is testing AV-1980R, a vaccine aimed at the tau protein in the brain which may be involved in Alzheimer's disease. Participants will receive different doses (20 µg, 60 µg, or 180 µg) or a placebo to assess safety and immune response. The study also looks at whether this vaccine can slow down disease progression.

How Is the Trial Designed?

Group I: AV-1980R 60 µg Arm Experimental Treatment 1 Intervention

Participants receive 60 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.

Group II: AV-1980R 20 µg Arm Experimental Treatment 1 Intervention

Participants receive 20 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.

Group III: AV-1980R 180 µg Arm Experimental Treatment 1 Intervention

Participants receive 180 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.

Group IV: Placebo Arm Placebo Group 1 Intervention

Participants receive placebo injections (10 mM phosphate buffer with the adjuvant, no antigen) at Weeks 0, 4, 12, and 36.

Who Is Running the Clinical Trial?

Institute for Molecular Medicine

Lead Sponsor

Trials

7

Recruited

3,700+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07158905

AV-1980R (Tau Vaccine) in Preclinical Alzheimer's ... This first-in-human study investigates AV-1980R, a MultiTEP-based active immunotherapy formulated with the adjuvant, as a secondary prevention ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9556597/

Immunogenicity of MultiTEP platform technology-based Tau ... These published data and efficacy results support the AV-1980R/A vaccine progression to first-in-human clinical trials. Subject terms ...

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

1 Last updated on February 18, 2025 Cognitive Vitality ... IND-enabling studies have been completed for the GMP-grade AV-1959D and cGMP grade AV-1980R vaccine with adjuvant (Hovakimyan et al., 2022). Vaccine development ...

4. nature.com nature.com/articles/srep28912

Alzheimer's disease Advax CpG - adjuvanted MultiTEP- ... AV-1959R and AV-1980R formulated with Advax CpG adjuvant were identified as promising immunogenic vaccines for ongoing pre-clinical assessment and future human ...

5. alzres.biomedcentral.com alzres.biomedcentral.com/articles/10.1186/s13195-019-0556-2

Testing a MultiTEP-based combination vaccine to reduce Aβ ... Recently, we demonstrated that the combination of AV-1959R and AV-1980R vaccines targeting Aβ and tau, respectively, induced robust antibody ...

6. withpower.com withpower.com/trial/phase-1-frontotemporal-dementia-11-2025-84985

AV-1980R Vaccine for Alzheimer's Disease This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose-escalating trial to evaluate the safety, tolerability, ...