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Study of AV-1959, an Amyloid Beta Vaccine

Primary Purpose

Alzheimer Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AV-1959D
Placebo
Sponsored by
Institute for Molecular Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female subjects from 60 to 85 years of age. 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. A positive visual Aβ positron emission tomography (PET) scan. Exclusion Criteria: 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 existing safety issues. Use of immunomodulatory or growth-stimulating factors within 30 days prior to study entry. 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 the use of excluded medications. Subjects with insulin-dependent diabetes. Subjects with pre-existing autoimmune diseases. A medical condition that in the opinion of the Investigator might be a contributing cause of cognitive impairment. History/evidence of severe local or systemic reactions to vaccination or significant allergic reactions. History of seizure disorder.

Sites / Locations

  • Banner Alzheimer's InstituteRecruiting
  • Hoag Memorial HospitalRecruiting
  • University of South FloridaRecruiting
  • Alzheimer's Research and Treatment CenterRecruiting
  • Accel ResearchRecruiting
  • Global Medical Institutes Princeton Medical InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

AV-1959D 500 μg

AV-1959D 1000 μg

AV-1959D 2000 μg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants with clinically significant changes in vital signs
Number of participants with clinically significant changes in ECG results
Number of participants with clinically significant changes in laboratory test
Number of participants with clinically significant changes in physical examinations
Number of participants with clinically significant changes in neurological examinations
Number of participants with Vasogenic edema (ARIA-E)
Number of participants with New cerebral ischemic or hemorrhagic events (ARIA-H) or associated symptoms
Number of participants with Change from baseline in C-SSRS Score
Concentration of possibly harmful autoreactive Th cell responses specific to Aβ
Concentration of Serum anti-Aβ antibodies
Concentration of Th cell responses specific to MultiTEP platform

Full Information

First Posted
November 30, 2022
Last Updated
September 15, 2023
Sponsor
Institute for Molecular Medicine
Collaborators
National Institute on Aging (NIA), Clinartis
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1. Study Identification

Unique Protocol Identification Number
NCT05642429
Brief Title
Study of AV-1959, an Amyloid Beta Vaccine
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
February 20, 2026 (Anticipated)
Study Completion Date
November 7, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Molecular Medicine
Collaborators
National Institute on Aging (NIA), Clinartis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AV-1959D 500 μg
Arm Type
Active Comparator
Arm Title
AV-1959D 1000 μg
Arm Type
Active Comparator
Arm Title
AV-1959D 2000 μg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
AV-1959D
Intervention Description
Three doses of AV-1959D administered as a sterile suspension via intradermal injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Three doses of Placebo administered as a sterile suspension via intradermal injection
Primary Outcome Measure Information:
Title
Number of participants with Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
Time Frame
Baseline up to Week 28 weeks
Secondary Outcome Measure Information:
Title
Number of participants with clinically significant changes in vital signs
Time Frame
Baseline up to Week 28
Title
Number of participants with clinically significant changes in ECG results
Time Frame
Baseline up to Week 28
Title
Number of participants with clinically significant changes in laboratory test
Time Frame
Baseline up to Week 28
Title
Number of participants with clinically significant changes in physical examinations
Time Frame
Screening up to Week 28
Title
Number of participants with clinically significant changes in neurological examinations
Time Frame
Screening up to Week 28
Title
Number of participants with Vasogenic edema (ARIA-E)
Time Frame
Screening, Weeks 8 and 28
Title
Number of participants with New cerebral ischemic or hemorrhagic events (ARIA-H) or associated symptoms
Time Frame
Screening, Weeks 8 and 28
Title
Number of participants with Change from baseline in C-SSRS Score
Time Frame
Baseline, Weeks 12 and 28
Title
Concentration of possibly harmful autoreactive Th cell responses specific to Aβ
Time Frame
Baseline, Week 8
Title
Concentration of Serum anti-Aβ antibodies
Time Frame
Baseline up to Week 28 post start of immunization with AV-1959D
Title
Concentration of Th cell responses specific to MultiTEP platform
Time Frame
Baseline, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects from 60 to 85 years of age. 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. A positive visual Aβ positron emission tomography (PET) scan. Exclusion Criteria: 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 existing safety issues. Use of immunomodulatory or growth-stimulating factors within 30 days prior to study entry. 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 the use of excluded medications. Subjects with insulin-dependent diabetes. Subjects with pre-existing autoimmune diseases. A medical condition that in the opinion of the Investigator might be a contributing cause of cognitive impairment. History/evidence of severe local or systemic reactions to vaccination or significant allergic reactions. History of seizure disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roman Kniazev
Phone
7145963981
Email
rkniazev@immed.org
First Name & Middle Initial & Last Name or Official Title & Degree
Anahit Ghochikyan, PhD
Phone
7145963981
Email
aghochikyan@immed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Agadjanyan, PhD
Organizational Affiliation
IMM
Official's Role
Study Director
Facility Information:
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Makenna Folkert
Phone
602-839-7617
Email
makenna.folkert@bannerhealth.com
Facility Name
Hoag Memorial Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrienne Swietlikowski
Phone
949-764-6797
Email
Adrienne.Swietlikowski@hoag.org
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Bannon
Phone
813-974-2832
Email
ybannon@usf.edu
Facility Name
Alzheimer's Research and Treatment Center
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tonya Blackwell
Phone
561-209-2400
Email
tblackwell@researchalz.com
Facility Name
Accel Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Clark
Phone
404-475-0552
Ext
2139
Email
rclark@accelclinical.com
First Name & Middle Initial & Last Name & Degree
Adrienne Hilliard
Phone
404-475-0558
Email
ahilliard@accelclinical.com
Facility Name
Global Medical Institutes Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaud Belleface
Phone
609-921-6050
Email
tbelleface@gminstitutes.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study of AV-1959, an Amyloid Beta Vaccine

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