Study of AV-1959, an Amyloid Beta Vaccine

Alzheimer Disease Clinical Trial

Official title:

A Phase I, Randomized, Double-Blind Study to Evaluate Safety and Tolerability of Amyloid-β Vaccine, AV-1959D, in Patients With Early Alzheimer's Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642429
• Other study ID #: IMM-AV1959D-101
• Secondary ID: R01AG074983
• Status: Recruiting
• Phase: Phase 1
• Start date: February 27, 2023
• Est. completion date: November 7, 2026

Study information

• Verified date: February 2024
• Source: Institute for Molecular Medicine
• Contact: Roman Kniazev
• Phone: 7145963981
• Email: rkniazev[@]immed.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 7, 2026
• Est. primary completion date: February 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

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

2. Mild cognitive impairment (MCI) due to Alzheimer's disease (AD), 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.

3. A positive visual Aß positron emission tomography (PET) scan.

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 existing safety issues.

4. Use of immunomodulatory or growth-stimulating factors within 30 days prior to study entry.

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

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

7. Subjects with insulin-dependent diabetes.

8. Subjects with pre-existing autoimmune diseases.

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

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

11. History of seizure disorder.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Biological:
• AV-1959D
Three doses of AV-1959D administered as a sterile suspension via intradermal injection
• Placebo
Three doses of Placebo administered as a sterile suspension via intradermal injection

Locations

Country	Name	City	State
United States	Accel Research	Decatur	Georgia
United States	Hoag Memorial Hospital	Newport Beach	California
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Global Medical Institutes Princeton Medical Institute	Princeton	New Jersey
United States	University of South Florida	Tampa	Florida
United States	Alzheimer's Research and Treatment Center	Wellington	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Institute for Molecular Medicine	Clinartis, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)		Baseline up to Week 28 weeks
Secondary	Number of participants with clinically significant changes in vital signs		Baseline up to Week 28
Secondary	Number of participants with clinically significant changes in ECG results		Baseline up to Week 28
Secondary	Number of participants with clinically significant changes in laboratory test		Baseline up to Week 28
Secondary	Number of participants with clinically significant changes in physical examinations		Screening up to Week 28
Secondary	Number of participants with clinically significant changes in neurological examinations		Screening up to Week 28
Secondary	Number of participants with Vasogenic edema (ARIA-E)		Screening, Weeks 8 and 28
Secondary	Number of participants with New cerebral ischemic or hemorrhagic events (ARIA-H) or associated symptoms		Screening, Weeks 8 and 28
Secondary	Number of participants with Change from baseline in C-SSRS Score		Baseline, Weeks 12 and 28
Secondary	Concentration of possibly harmful autoreactive Th cell responses specific to Aß		Baseline, Week 8
Secondary	Concentration of Serum anti-Aß antibodies		Baseline up to Week 28 post start of immunization with AV-1959D
Secondary	Concentration of Th cell responses specific to MultiTEP platform		Baseline, Week 8