AV-1959R Vaccine in Individuals With Preclinical Alzheimer's Disease

ConditionsPreclinical Alzheimer's Disease Alzheimer Disease

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age55-80

SponsorInstitute for Molecular Medicine

About this trial

This Phase 2 study will evaluate the safety, tolerability, immunogenicity, and amyloid-lowering effect of AV-1959R in cognitively unimpaired adults with preclinical Alzheimer's disease. Approximately 160 participants will be randomized to receive AV-1959R or placebo and will be followed for 78 weeks. The study will assess safety, immune responses, brain amyloid, and Alzheimer's disease-related biomarkers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

AV-1959R
Biological/Vaccine
Investigational amyloid-beta vaccine, AV-1959R, 100 micrograms, administered intramuscularly with adjuvant at Weeks 0, 4, and 44.
Placebo
Drug
Placebo administered by intramuscular injection with adjuvant at Weeks 0, 4, and 44.

Treatment groups

160 Participants

are divided into 2 treatment groups

Group A: AV-1959RExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Number and percentage of participants with treatment-emergent adverse events.

Time frame

From first study intervention through Week 78

Incidence of ARIA-E and ARIA-H

Number and percentage of participants with MRI-detected amyloid-related imaging abnormalities, including ARIA-E and ARIA-H.

Time frame

Through Week 78

Clinically Significant Changes in Safety Assessments

Number and percentage of participants with clinically significant changes in vital signs, ECG, laboratory assessments, physical examinations, or neurological examinations.

Time frame

Through Week 78

Change From Baseline in Columbia-Suicide Severity Rating Scale Suicidal Ideation Severity Score

Change from baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation severity score, comparing AV-1959R and placebo groups. The score ranges from 0 to 5, with higher scores indicating greater severity of suicidal ideation.

Time frame

Baseline and Weeks 4, 44, and 78

Secondary outcomes

T-cell responses to MultiTEP and amyloid-beta

Assessment of MultiTEP-specific T-cell responses and autoreactive anti-amyloid-beta T-cell responses, comparing AV-1959R and placebo groups.

Time frame

Baseline through Week 78

Change From Baseline in Global Brain Amyloid Burden

Change from baseline in global brain amyloid burden measured by amyloid PET using the Centiloid scale, comparing the AV-1959R and placebo groups.

Time frame

Baseline to Week 78

Change From Baseline in Plasma p-tau217/Aβ1-42 Ratio

Change from baseline in plasma Lumipulse p-tau217/Aβ1-42 ratio, comparing the AV-1959R and placebo groups.

Time frame

Baseline through Week 78

Other outcomes

Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score

Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score, comparing AV-1959R and placebo groups. The total score ranges from 0 to 18, with higher scores indicating greater cognitive and functional impairment.

Time frame

Baseline to Week 78

Change From Baseline in Plasma Amyloid Biomarkers

Change from baseline in plasma Aβ42, Aβ40, and Aβ42/Aβ40 ratio, comparing the AV-1959R and placebo groups.

Time frame

Baseline through Week 78

Change From Baseline in Plasma Tau Biomarker Concentrations

Change from baseline in plasma concentrations of BD-tau, MTBR-tau243, total tau, p-tau181, p-tau231, and p-tau217.

Time frame

Baseline through Week 78

Change From Baseline in Plasma Neurofilament Light Chain Concentration

Change from baseline in plasma neurofilament light chain (NfL) concentration.

Time frame

Baseline through Week 78

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute for Molecular Medicine

Lead sponsor

Nuravax, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: