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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 up to 5 years
Awards & highlights
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.
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.
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial 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
1,733 Previous Clinical Trials
28,054,955 Total Patients Enrolled
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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.
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