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AREVIA
Not yet recruitingPhase 2AV-1959R Vaccine in Individuals With Preclinical Alzheimer's Disease
A Phase II, Randomized, Double-Blind Study to Evaluate Safety, Tolerability, Immunogenicity, and Amyloid-Lowering Effect of Amyloid-β Vaccine, AV-1959R, in Individuals With Preclinical Alzheimer's Disease.
Lead sponsor
Asset
AV-1959R
Listed sites
0
Recruiting sites
-
Enrollment
160
estimated
Study population
Alzheimer’s disease
Key I/E criteria
•Preclinical/asymptomatic AD•CDR global 0•MRI contraindications excluded•Brain MRI excludes superficial siderosis
Primary endpoints
•Treatment-Emergent Adverse Events (TEAEs)•ARIA-E and ARIA-H•Clinically Significant Changes in Safety Assessments
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Male or female participants 55 to 80 years of age, inclusive, at screening. Signed informed consent before initiation of study-related procedures.
Cognitively unimpaired participants with preclinical Alzheimer's disease meeting all of the following:
CDR global score = 0 at screening. MMSE score ≥26 at screening, with education adjustment. WMS-R LM2 score ≥ 6 Plasma p-tau217/Aβ1-42 ratio ≥0.00738. Brain amyloid burden ≥ 20CL. Vision and hearing sufficient to comply with study procedures, in the investigator's judgment.
Stable concomitant medications for management of existing medical conditions, as appropriate.
Women must be of non-childbearing potential as defined in the protocol. Men must meet protocol-defined contraception and sperm donation requirements. Ability, in the investigator's opinion, to understand the study and comply with study requirements
Exclusion criteria
Screening MRI showing clinically significant abnormalities, including protocol-defined infarcts, excessive microbleeds, leptomeningeal hemosiderosis, superficial siderosis, or ARIA-E.
Contraindication to MRI. Serious illness requiring systemic treatment and/or hospitalization within 4 weeks before study entry.
Clinically relevant cardiovascular, respiratory, gastrointestinal, endocrine, immunologic, hematologic, neurologic, or other systemic disease that could interfere with participation or follow-up.
Insulin-dependent diabetes. Clinically significant ECG abnormalities, including protocol-defined conduction abnormalities or QTc abnormalities.
Pre-existing autoimmune disease. History of seizure disorder, except protocol-permitted use of certain antiepileptic medications for chronic pain.
Any medical, psychological, or social condition that may interfere with participation, compliance, or safety.
Participation in another investigational drug study or use of an investigational drug within 30 days or 5 half-lives, whichever is longer, before dosing.
Prior amyloid-beta or tau immunotherapy, including vaccine or monoclonal antibody, within 1 year before screening.
Recent use of protocol-defined immunomodulatory or growth-stimulating agents. Chronic use of protocol-defined anticoagulants or antiplatelet agents; aspirin is permitted.
Parenteral use of immunoglobulin preparations, blood products, or plasma derivatives.
History of severe local or systemic vaccine reactions or significant allergic reactions.
Clinically significant laboratory abnormalities at screening. Positive testing for HIV-1/2, hepatitis B surface antigen, or hepatitis C virus.
Endpoints (15)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
1 endpointChange From Baseline in Clinical Dementia Rating-Sum of Boxes Score
Time frame:Baseline to Week 78
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
change from baseline, improvement
Amyloid biomarkers
6 endpointsIncidence of ARIA-E and ARIA-H
Time frame:Through Week 78
threshold achievement, improvement
Serum Anti-Amyloid-Beta Antibody Levels
Time frame:Baseline through Week 78
descriptive
T-cell responses to MultiTEP and amyloid-beta
Time frame:Baseline through Week 78
descriptive
Change From Baseline in Global Brain Amyloid Burden
Time frame:Baseline to Week 78
Amyloid PET Centiloid
change from baseline, improvement
Change From Baseline in Plasma p-tau217/Aβ1-42 Ratio
Time frame:Baseline through Week 78
Phosphorylated tau 217 (p-tau217)
change from baseline, improvement
Change From Baseline in Plasma Amyloid Biomarkers
Time frame:Baseline through Week 78
change from baseline, improvement
Tau biomarkers
2 endpointsChange From Baseline in Plasma Tau Biomarker Concentrations
Time frame:Baseline through Week 78
Phosphorylated tau 217 (p-tau217)
change from baseline, improvement
Change From Baseline in Brain Tau Burden
Time frame:Baseline to Week 78
change from baseline, improvement
Neurodegeneration biomarkers
2 endpointsChange From Baseline in Plasma Neurofilament Light Chain Concentration
Time frame:Baseline through Week 78
Neurofilament light (NfL)
change from baseline, improvement
Change From Baseline in Plasma Glial Fibrillary Acidic Protein Concentration
Time frame:Baseline through Week 78
change from baseline, improvement
Safety / tolerability / PK
2 endpointsIncidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame:From first study intervention through Week 78
threshold achievement, event
Clinically Significant Changes in Safety Assessments
Time frame:Through Week 78
threshold achievement, event
Other (unclassified)
2 endpointsChange From Baseline in Columbia-Suicide Severity Rating Scale Suicidal Ideation Severity Score
Time frame:Baseline and Weeks 4, 44, and 78
change from baseline, improvement
Changes in T-Cell and B-Cell Receptor Repertoires and Lineages
Time frame:Baseline through Week 78
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.