Study of AV-1959D, an Amyloid Beta Vaccine

NCT05642429 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IMM-AV1959D-101R01AG074983
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)

  Baseline up to Week 28 weeks

Secondary Outcomes (9)

• Number of participants with clinically significant changes in vital signs

  Baseline up to Week 28

• Number of participants with clinically significant changes in ECG results

  Baseline up to Week 28

• Number of participants with clinically significant changes in laboratory test

  Baseline up to Week 28

• Number of participants with clinically significant changes in physical examinations

  Screening up to Week 28

• Number of participants with clinically significant changes in neurological examinations

  Screening up to Week 28

Study Arms (4)

AV-1959D 500 μg

ACTIVE COMPARATOR

Biological: AV-1959D

AV-1959D 1000 μg

ACTIVE COMPARATOR

Biological: AV-1959D

AV-1959D 2000 μg

ACTIVE COMPARATOR

Biological: AV-1959D

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

AV-1959D BIOLOGICAL

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

AV-1959D 1000 μg; AV-1959D 2000 μg; AV-1959D 500 μg

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects from 60 to 85 years of age, both inclusive.
• 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.
• 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.
• 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.
• The subject's sight and hearing (hearing aid permissible) are sufficient for compliance with the study procedures.
• Signed informed consent form by the subject and study partner prior to study participation.

You may not qualify if:

• 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.
• Prior administration of any amyloid-beta or tau immunotherapy (vaccine, antibody)
• 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.
• 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.
• 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.
• 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.
• Parenteral use of immunoglobulin preparations, blood products, plasma derivatives.
• Any serious illness requiring systemic treatment and/or hospitalization within 4 weeks prior to study entry.
• Any major or unstable illness, including unstable ischemic cardiovascular disease, or require use of excluded medications.
• 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.
• Subjects with insulin-dependent diabetes.

Sponsors & Collaborators

• Institute for Molecular Medicine: lead
• National Institute on Aging (NIA): collaborator
• Clinartis: collaborator

Study Sites (6)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Alzheimer's Research and Treatment Center

Wellington, Florida, 33414, United States

Location

Accel Research

Decatur, Georgia, 30033, United States

Location

Global Medical Institutes Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Michael Agadjanyan, PhD

  IMM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: February 27, 2023
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): November 7, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (6)