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Cancer Vaccine
Alzheimer's Disease Vaccine for Alzheimer's Disease
Phase 1
Recruiting
Research Sponsored by Institute for Molecular Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 28 post start of immunization with av-1959d
Awards & highlights
Study Summary
This trial tests a vaccine to prevent Alzheimer's Disease.
Who is the study for?
This trial is for men and women aged 60-85 with mild cognitive impairment due to Alzheimer's, scoring 22-30 on the MMSE and having a CDR of 0.5 or 1.0. They must have evidence of amyloid-beta in the brain via PET scan but can't join if they've had recent other treatments, immunotherapies for Alzheimer's, serious illnesses, unstable heart disease, insulin-dependent diabetes, autoimmune diseases, severe reactions to vaccines or seizures.Check my eligibility
What is being tested?
The study tests AV-1959D vaccine against a placebo in people with early Alzheimer's symptoms. It’s a Phase 1 trial designed to evaluate safety and how well participants tolerate the vaccine while monitoring any potential impact on their cognitive function over time.See study design
What are the potential side effects?
Potential side effects are not specified but may include typical vaccine-related reactions such as soreness at injection site, fever or fatigue. Serious allergic reactions could occur given the exclusion criteria related to past vaccination reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to week 28 post start of immunization with av-1959d
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 28 post start of immunization with av-1959d
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
Secondary outcome measures
Concentration of Serum anti-Aβ antibodies
Concentration of Th cell responses specific to MultiTEP platform
Concentration of possibly harmful autoreactive Th cell responses specific to Aβ
+8 moreTrial Design
4Treatment groups
Active Control
Placebo Group
Group I: AV-1959D 2000 μgActive Control1 Intervention
Group II: AV-1959D 1000 μgActive Control1 Intervention
Group III: AV-1959D 500 μgActive Control1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Institute for Molecular MedicineLead Sponsor
6 Previous Clinical Trials
3,642 Total Patients Enrolled
ClinartisIndustry Sponsor
6 Previous Clinical Trials
222 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,674 Previous Clinical Trials
28,020,857 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't been part of another drug study or taken any experimental drugs recently.I haven't been hospitalized or needed serious treatment in the last 4 weeks.I use insulin for my diabetes.I have previously received a vaccine or antibody for amyloid-beta or tau.I have a history of seizures.I am between 60 and 85 years old.I have mild memory problems due to Alzheimer's, confirmed by tests and a PET scan.I haven't used any immune-boosting or growth-stimulating drugs in the last 30 days.I do not have any major or unstable illnesses or need medications that are not allowed.
Research Study Groups:
This trial has the following groups:- Group 1: AV-1959D 2000 μg
- Group 2: AV-1959D 1000 μg
- Group 3: Placebo
- Group 4: AV-1959D 500 μg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what population is this clinical trial open?
"For consideration in this clinical trial, prospective participants should be aged between 60 and 85 with a diagnosis of Alzheimer's disease. The study is currently looking to enrol 48 individuals."
Answered by AI
Has the FDA officially sanctioned AV-1959D 2000 μg?
"Our research team at Power has rated the safety of AV-1959D 2000 μg a 1 due to its preliminary phase in development, implying that there is minimal clinical data regarding both its efficacy and security."
Answered by AI
What is the current count of healthcare centers conducting this clinical trial?
"At this time, the trial is running in 6 hospitals across the nation. Examples include Phoenix, Newport Beach and Wellington alongside 3 other clinics. To reduce travel requirements, we recommend selecting a clinic that is close to your current location if you decide to join."
Answered by AI
Is the team currently seeking participants for this research project?
"Clinicaltrials.gov indicates that this trial, which was first posted on December 5th 2022 and underwent its most recent update two days later, is not currently recruiting patients. However, there are 555 other experiments actively looking for volunteers right now."
Answered by AI
Are individuals below the age of seventy precluded from participating in this medical research?
"This clinical trial requires potential participants to be between 60-85 years old, with no exceptions."
Answered by AI
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