Alzheimer DiseasePhase 1NCT05642429
Study of AV-1959D, an Amyloid Beta Vaccine
A Phase 1 study testing AV-1959D in people with Alzheimer Disease, run by Institute for Molecular Medicine at 6 sites in United States.
Trial summary
Phase 1 clinical trial of AV-1959 amyloid-β vaccine for Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- AV-1959D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Feb 2023to 11 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- A positive visual Aβ positron emission tomography (PET) scan. Previously obtained PET scan (within 24 months of screening) is permissible and must be submitted to the central imaging reader to confirm that study inclusion criteria are met.
- 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.
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- 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.
Who cannot join
- 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)
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- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Accel Research
Decatur, Georgia, 30033
Hoag Memorial Hospital
Newport Beach, California, 92663
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Global Medical Institutes Princeton Medical Institute
Princeton, New Jersey, 08540
University of South Florida
Tampa, Florida, 33613
Alzheimer's Research and Treatment Center
Wellington, Florida, 33414
About this study
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.
Phase 1 clinical trial of AV-1959 amyloid-β vaccine for Alzheimer's disease (AD).
Read the 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
- Being tested
- AV-1959D, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-1959DBiological
Three doses of AV-1959D administered as a sterile suspension via intradermal injection
PlaceboBiological
Three doses of Placebo administered as a sterile suspension via intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| AV-1959D 500 μg | Active comparator | Not described Receives: Biological: AV-1959D |
| AV-1959D 1000 μg | Active comparator | Not described Receives: Biological: AV-1959D |
| AV-1959D 2000 μg | Active comparator | Not described Receives: Biological: AV-1959D |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
Measured: Baseline up to Week 28 weeks
Secondary outcomes (9)
Number of participants with clinically significant changes in vital signs
Measured: Baseline up to Week 28
Number of participants with clinically significant changes in ECG results
Measured: Baseline up to Week 28
Number of participants with clinically significant changes in laboratory test
Measured: Baseline up to Week 28
Number of participants with clinically significant changes in physical examinations
Measured: Screening up to Week 28
Number of participants with clinically significant changes in neurological examinations
Measured: Screening up to Week 28
Number of participants with Vasogenic edema (ARIA-E)
Measured: Screening, Weeks 8 and 28
Number of participants with New cerebral ischemic or hemorrhagic events (ARIA-H) or associated symptoms
Measured: Screening, Weeks 8 and 28
Number of participants with Change from baseline in C-SSRS Score
Measured: Baseline, Weeks 12 and 28
Immunological outcome
- Detection of possibly harmful autoreactive Th cell responses specific to Aβ.
- Serum anti-Aβ antibodies concentrations.
- Detection of Th cell responses specific to the MultiTEP platform.
Measured: Baseline and up to Week 28 post start of immunization with AV-1959D
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start27 Feb 2023
- Primary completion2 Aug 2025
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Molecular Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Clinartis
- Responsible party
- Sponsor
- Investigators
- Michael Agadjanyan, PhD, Study director, IMM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642429
- Sponsor's protocol ID
- IMM-AV1959D-101
- Other IDs
- R01AG074983
- Status last verified
- Mar 2026
- First submitted
- 30 Nov 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05642429
- Acronym / sponsor ID
- IMM-AV1959D-101
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Institute for Molecular MedicineUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Clinartis
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 2 Aug 2025 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- A positive visual Aβ positron emission tomography (PET) scan. Previously obtained PET scan (within 24 months of screening) is permissible and must be submitted to the central imaging reader to confirm that study inclusion criteria are met.
- 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.
Key exclusion criteria (21 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV-1959DThree doses of AV-1959D administered as a sterile suspension via intradermal injection | Biological | AV-1959D 1000 μg, AV-1959D 2000 μg, AV-1959D 500 μg |
| PlaceboThree doses of Placebo administered as a sterile suspension via intradermal injection | Biological | Placebo |
Primary outcome
Number of participants with Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 28 weeks
9 secondary outcomes
Number of participants with clinically significant changes in vital signs
Time frame: Baseline up to Week 28
Number of participants with clinically significant changes in ECG results
Time frame: Baseline up to Week 28
Number of participants with clinically significant changes in laboratory test
Time frame: Baseline up to Week 28
Number of participants with clinically significant changes in physical examinations
Time frame: Screening up to Week 28
Number of participants with clinically significant changes in neurological examinations
Time frame: Screening up to Week 28
Number of participants with Vasogenic edema (ARIA-E)
Time frame: Screening, Weeks 8 and 28
Number of participants with New cerebral ischemic or hemorrhagic events (ARIA-H) or associated symptoms
Time frame: Screening, Weeks 8 and 28
Number of participants with Change from baseline in C-SSRS Score
Time frame: Baseline, Weeks 12 and 28
Immunological outcome
Time frame: Baseline and up to Week 28 post start of immunization with AV-1959D
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Agadjanyan, PhD study director
IMM
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AV-1959D in people with Alzheimer Disease, run by Institute for Molecular Medicine at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) (time frame: Baseline up to Week 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.