Study of AV-1959D, an Amyloid Beta Vaccine

NCT ID: NCT05642429

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-27
• Study Completion Date: 2026-11-07

Brief Summary

Phase 1 clinical trial of AV-1959 amyloid-β vaccine for Alzheimer's disease (AD).

Detailed Description

The Phase I study is a randomized, multicenter, double-blind, placebo-controlled study consisting of 3 sequential cohorts to determine the safety and tolerability of AV-1959D at three doses compared to a placebo in patients with early AD

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AV-1959D 500 μg

Group Type: ACTIVE_COMPARATOR

AV-1959D

Intervention Type: BIOLOGICAL

Three doses of AV-1959D administered as a sterile suspension via intradermal injection

AV-1959D 1000 μg

Group Type: ACTIVE_COMPARATOR

AV-1959D

Intervention Type: BIOLOGICAL

Three doses of AV-1959D administered as a sterile suspension via intradermal injection

AV-1959D 2000 μg

Group Type: ACTIVE_COMPARATOR

AV-1959D

Intervention Type: BIOLOGICAL

Three doses of AV-1959D administered as a sterile suspension via intradermal injection

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Three doses of Placebo administered as a sterile suspension via intradermal injection

Interventions

AV-1959D

Three doses of AV-1959D administered as a sterile suspension via intradermal injection

Intervention Type: BIOLOGICAL

Placebo

Three doses of Placebo administered as a sterile suspension via intradermal injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects from 60 to 85 years of age, both inclusive.

2. Mild cognitive impairment (MCI) due to Alzheimer's disease (AD), according to Albert et al., or mild AD dementia, according to McKhann et al., and must have the following:

• Mini-Mental State Examination (MMSE) score from 22 to 30;
• Clinical Dementia Rating (CDR) global score of 0.5 or 1.0.

4. Subjects on approved AD medications (e.g., acetylcholine esterase inhibitors, memantine) are required to be on a stable dose for a minimum 3 months before baseline and with no dosage adjustments expected during the study. Continuation of subjects with dose adjustments for approved AD medications during the study may be allowed after discussion between the Investigator and the Medical Monitor.

5. The subject has a reliable study partner who will accompany the patient to all clinic visits during the study and, in the Investigator's opinion, has frequent and sufficient contact with the subject as to be able to provide accurate information about the subject's cognitive and functional abilities.

6. The subject's sight and hearing (hearing aid permissible) are sufficient for compliance with the study procedures.

7. Signed informed consent form by the subject and study partner prior to study participation.

Exclusion Criteria

1. Participation in another investigational drug or device study or treated with an investigational drug within 30 days or 5 half-lives, whichever is longer, before dosing.

2. Prior administration of any amyloid-beta or tau immunotherapy (vaccine, antibody)

3. Magnetic resonance imaging (MRI) showing evidence of any of the following:

• More than 1 lacunar infarct greater than 1.5 cm
• Any territorial infarct, including acute or chronic, greater than 1.5 cm
• Subjects who have a combined number of microbleeds and areas of leptomeningeal hemosiderosis (i.e., cumulative ARIA-H) on the MRI of > 5 (and should not include any disseminated leptomeningeal hemosiderosis)
• Subjects who have a presence of any other significant cerebral abnormalities, including ARIA-E, as assessed in the screening MRI scan.

4. Contraindications for MRI scanning, including implanted metallic devices (e.g., non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces.

5. Use of immunomodulatory or growth-stimulating factors such as systemic corticosteroids, cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, GM-CSF, C-CSF, interferon (IFN), or interleukin-2 (IL-2) within 30 days prior to study entry.

6. Concurrent use of warfarin or other coumarin derivatives or a combination of acetylsalicylic acid and an anti-platelet agent (e.g., clopidogrel). Low dose of acetylsalicylic acid (≤81 mg per day) is allowed.

7. Parenteral use of immunoglobulin preparations, blood products, plasma derivatives.

8. Any serious illness requiring systemic treatment and/or hospitalization within 4 weeks prior to study entry.

9. Any major or unstable illness, including unstable ischemic cardiovascular disease, or require use of excluded medications.

10. History/evidence of clinically relevant pathology related to cardiovascular system, respiratory tract, gastrointestinal tract, endocrinology, immunology, hematology, or any other systemic disorder/major surgeries that in the opinion of the Investigator would confound the subject's participation and follow-up in the clinical study.

11. Subjects with insulin-dependent diabetes.

12. Cardiac arrhythmias or palpitations [e.g., supraventricular tachycardia, atrial fibrillation, frequent ectopy, or sinus bradycardia]. Cardiac conduction abnormalities to be specified including prolonged QT interval and bundle branch blocks.

13. Subjects with pre-existing autoimmune diseases.

14. A medical condition that in the opinion of the Investigator might be a contributing cause of cognitive impairment.

15. History/evidence of severe local or systemic reactions to vaccination or significant allergic reactions.

16. History of seizure disorder.

17. Any other medical, psychological, social condition or diagnostic test which, in the opinion of the Investigator and Medical Monitor may lead to screen failure or prevent the subject from fully participating in the study, represent a concern for study compliance, or constitute a safety concern to the subject.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Clinartis

INDUSTRY

Sponsor Role: collaborator

Institute for Molecular Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Agadjanyan, PhD

Role: STUDY_DIRECTOR

IMM

Locations

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Hoag Memorial Hospital

Newport Beach, California, United States

University of South Florida

Tampa, Florida, United States

Alzheimer's Research and Treatment Center

Wellington, Florida, United States

Accel Research

Decatur, Georgia, United States

Global Medical Institutes Princeton Medical Institute

Princeton, New Jersey, United States

Countries

United States

Other Identifiers

R01AG074983

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IMM-AV1959D-101

Identifier Type: -

Identifier Source: org_study_id