Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of AV-1959, an Amyloid Beta Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05642429
Recruitment Status : Recruiting
First Posted : December 8, 2022
Last Update Posted : April 11, 2023
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Clinartis
Information provided by (Responsible Party):
Institute for Molecular Medicine

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Phase 1 clinical trial of AV-1959 amyloid-β vaccine for Alzheimer's disease (AD).

Condition or disease Intervention/treatment Phase
Alzheimer Disease Biological: AV-1959D Biological: Placebo Phase 1

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : February 27, 2023
Estimated Primary Completion Date : February 20, 2026
Estimated Study Completion Date : November 7, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: AV-1959D 500 μg Biological: AV-1959D
Three doses of AV-1959D administered as a sterile suspension via intradermal injection
Active Comparator: AV-1959D 1000 μg Biological: AV-1959D
Three doses of AV-1959D administered as a sterile suspension via intradermal injection
Active Comparator: AV-1959D 2000 μg Biological: AV-1959D
Three doses of AV-1959D administered as a sterile suspension via intradermal injection
Placebo Comparator: Placebo Biological: Placebo
Three doses of Placebo administered as a sterile suspension via intradermal injection


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants with Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 28 weeks ]

Secondary Outcome Measures :
  1. Number of participants with clinically significant changes in vital signs [ Time Frame: Baseline up to Week 28 ]
  2. Number of participants with clinically significant changes in ECG results [ Time Frame: Baseline up to Week 28 ]
  3. Number of participants with clinically significant changes in laboratory test [ Time Frame: Baseline up to Week 28 ]
  4. Number of participants with clinically significant changes in physical examinations [ Time Frame: Screening up to Week 28 ]
  5. Number of participants with clinically significant changes in neurological examinations [ Time Frame: Screening up to Week 28 ]
  6. Number of participants with Vasogenic edema (ARIA-E) [ Time Frame: Screening, Weeks 8 and 28 ]
  7. Number of participants with New cerebral ischemic or hemorrhagic events (ARIA-H) or associated symptoms [ Time Frame: Screening, Weeks 8 and 28 ]
  8. Number of participants with Change from baseline in C-SSRS Score [ Time Frame: Baseline, Weeks 12 and 28 ]
  9. Concentration of possibly harmful autoreactive Th cell responses specific to Aβ [ Time Frame: Baseline, Week 8 ]
  10. Concentration of Serum anti-Aβ antibodies [ Time Frame: Baseline up to Week 28 post start of immunization with AV-1959D ]
  11. Concentration of Th cell responses specific to MultiTEP platform [ Time Frame: Baseline, Week 8 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Aβ 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05642429


Contacts
Layout table for location contacts
Contact: Roman Kniazev 7145963981 rkniazev@immed.org
Contact: Anahit Ghochikyan, PhD 7145963981 aghochikyan@immed.org

Locations
Layout table for location information
United States, Arizona
Banner Alzheimer's Institute Recruiting
Phoenix, Arizona, United States, 85006
Contact: Makenna Folkert    602-839-7617    makenna.folkert@bannerhealth.com   
United States, California
Hoag Memorial Hospital Recruiting
Newport Beach, California, United States, 92663
Contact: Adrienne Swietlikowski    949-764-6797    Adrienne.Swietlikowski@hoag.org   
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33613
Contact: Yvonne Bannon    813-974-2832    ybannon@usf.edu   
Alzheimer's Research and Treatment Center Recruiting
Wellington, Florida, United States, 33414
Contact: Tonya Blackwell    561-209-2400    tblackwell@researchalz.com   
United States, Georgia
Accel Research Not yet recruiting
Decatur, Georgia, United States, 30033
Contact: Roman Kniazev         
United States, New Jersey
Global Medical Institutes Princeton Medical Institute Recruiting
Princeton, New Jersey, United States, 08540
Contact: Thibaud Belleface    609-921-6050    tbelleface@gminstitutes.com   
Sponsors and Collaborators
Institute for Molecular Medicine
National Institute on Aging (NIA)
Clinartis
Investigators
Layout table for investigator information
Study Director: Michael Agadjanyan, PhD IMM
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Institute for Molecular Medicine
ClinicalTrials.gov Identifier: NCT05642429    
Other Study ID Numbers: IMM-AV1959D-101
R01AG074983 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2022    Key Record Dates
Last Update Posted: April 11, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders