Preclinical Alzheimer's Disease study: AADvac1 vs Tau2
Official title Alzheimer's Tau Platform: Master Protocol
ClinicalTrials.gov ID: NCT06957418
What this study is testing
What is AADvac1?
an investigational vaccine being studied as a potential treatment for preclinical Alzheimer's disease is designed to stimulate an immune response against abnormal tau protein in the brain
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a tau‑directed therapy, alone or with donanemab, can lower brain tau and slow disease. It also looks at how safe the treatments are.
- Who it's for
- You may be able to join if you are 50‑80 years old and have early signs of Alzheimer’s before memory loss is severe.
- What's involved
- You will be randomly assigned to one of three groups: a tau drug alone, the tau drug plus donanemab, or donanemab alone. You will receive a placebo or donanemab for six months, then the chosen treatment for 24 months. You will have regular memory tests, brain scans, and blood checks over 30 months.
- Time commitment
- The study lasts about 30 months and includes visits for tests and scans every few months.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 30 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- Documentation of the participant's informed consent to study procedures (including APOE genotyping).
- Ages 50-80 years (inclusive). Participants between the ages of 50 and 60 (inclusive) must be mildly impaired at screening (global CDR=0.5 and maximum...
- Cognitively unimpaired (preclinical AD with a global CDR=0) or mildly impaired (prodromal AD with a global CDR=0.5 and maximum CDR-SB \<1.5).
- If \ 20.
- If 13 to 15 years (inclusive) of education, MMSE required to be \>22.
You likely can't join if
- Females who are lactating or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study.
- Females of childbearing potential who did not use a highly effective method of contraception within 28 days of screening and/or are not willing to...
- Lacks good venous access such that multiple blood draws would be precluded.
- Weighs less than 40kg, or more than 136kg at screening.
- Suspected or known allergic reactions, adverse reactions, or hypersensitivity to any components of the study intervention for any of the available...
- Previous treatment with the study intervention from any available regimen unless it can be confirmed the participant received placebo in the previous...
See the full eligibility criteria
Who can join
- Documentation of the participant's informed consent to study procedures (including APOE genotyping).
- Ages 50-80 years (inclusive). Participants between the ages of 50 and 60 (inclusive) must be mildly impaired at screening (global CDR=0.5 and maximum CDR-SB \<1.5
- Cognitively unimpaired (preclinical AD with a global CDR=0) or mildly impaired (prodromal AD with a global CDR=0.5 and maximum CDR-SB \<1.5).
- If \ 20.
- If 13 to 15 years (inclusive) of education, MMSE required to be \>22.
- If \>16 years of education, MMSE required to be \>24.
- Plasma biomarker result at screening that demonstrate the presence of amyloid pathology, consistent with preclinical-prodromal AD.
- Elevated brain tau on PET (MTL or NEO tau SUVr \>1.2) at screening.
- Elevated brain amyloid on PET (centiloids \> 40) at screening.
- Stable doses of permitted medications as described per protocol for a minimum of 30 days prior to screening.
- Resides at home or in the community (assisted living acceptable).
- In the opinion of the site PI, has a study partner able and willing to provide accurate information (including clinical symptoms and medical history) about the participant and participate in study visits and...
- As assessed by the site PI, participant is likely to be able to comply with the protocol for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy (English or Spanish)...
- Must complete all screening evaluations as outlined per protocol.
What rules you out
- Females who are lactating or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study.
- Females of childbearing potential who did not use a highly effective method of contraception within 28 days of screening and/or are not willing to use highly effective method of contraception for the duration of their...
- Lacks good venous access such that multiple blood draws would be precluded.
- Weighs less than 40kg, or more than 136kg at screening.
- Suspected or known allergic reactions, adverse reactions, or hypersensitivity to any components of the study intervention for any of the available regimen.
- Previous treatment with the study intervention from any available regimen unless it can be confirmed the participant received placebo in the previous study.
- Prior or current treatment with a prohibited medication as described per protocol.
- Enrollment in another investigational study as described per protocol. Participants enrolled in an observational study may be permitted with Medical Monitor review and approval.
- Contraindications to MRI studies, including metal (ferromagnetic) implants, a cardiac pacemaker that is not compatible with MRI, and/or severe claustrophobia.
- MRI scan at screening showing a single area of cerebral vasogenic edema, superficial siderosis, or showing more than four (4) cerebral microhemorrhages (defined as 10 mm or less at the greatest diameter)
- Contraindications to tau and/or amyloid PET scan imaging and/or use of MK6240 and/or 18F-NAV-4694 (flutafuranol).
- For participants undergoing an LP as part of the optional longitudinal CSF biomarker sub-study, contraindication to undergoing an LP including, but not limited to: inability to tolerate an appropriately flexed position...
- Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or how well it works of study drug (e.g., moderate and/or severe untreated obstructive sleep apnea, clinically...
- History of severe allergic reaction (e.g., anaphylaxis) including, but not limited to: severe allergic reaction to previous vaccines, foods, and/or medications.
- Hospitalization within 30 days prior to screening or baseline.
- Clinically significant infections or major surgical operation within 3 months prior to screening.
- History of chronic or recurrent infections judged to be clinically significant by the site PI and which would potentially hamper the evaluation of how well it works and safety assessments.
- Myocardial infarction within 1 year prior to baseline, unstable angina pectoris, or significant coronary artery disease.
- History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in-situ, in-situ prostate cancer, or in-situ breast cancer, which have been fully removed and are...
- History of inflammatory neurological disorders.
- History or presence of immunological or inflammatory conditions, including neurological disorders, judged to be clinically significant by the site PI.
- History of meningitis or meningoencephalitis.
- History of moderate or severe traumatic brain injury.
- History or presence of uncontrolled seizures. If history of seizures, they must be well controlled with no occurrence of seizures in the 2 years prior to study screening.
- Concomitant or past history of psychiatric or neurologic disorder other than those considered to be related to AD (e.g., head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid...
- DSM-5 criteria for drug or alcohol abuse or dependence currently met within the past 5 years.
- Significant risk of suicide defined, using the C-SSRS, as the participant answering "yes" to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behavior within the past 6 months.
- Clinically significant abnormal vital signs including sustained sitting blood pressure \>160/90 mm Hg.
- Participants with diabetes mellitus with hemoglobin A1c (HbA1c) levels of \>7.5%.
- hematocrit less than 35% for those with male biological sex and less than 32% for those with female biological sex.
- absolute neutrophil cell count \<1500/uL (with the exception of a chronic benign neutropenia).
- absolute lymphocyte count \<900/uL.
- platelet cell count of \<100,000/uL.
- INR \>1.4 or other coagulopathy, confirmed by repeat (not applicable for participants on anticoagulation).
- Participants with a known history of human immunodeficiency virus infection (HIV-1 and 2).
- Participants with known history of acute/chronic hepatitis B or C.
- Chronic liver disease.
- Respiratory insufficiency.
- Renal insufficiency defined as estimated glomerular filtration rate (eGFR) \<50 mL/min based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
- Bradycardia (\ 100/min). Bradycardia \>40/min and \<50/min may be permitted with review and approval by the Medical Monitor.
- Clinically significant arrhythmias or other clinically significant abnormalities on ECG at screening (minor abnormalities documented as clinically insignificant by the site PI are allowed).
- Any condition, which in the opinion of the site PI, Coordinating Center, or Project Lead/Protocol PI, makes the participant unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- San Francisco, California, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- Providence, Rhode Island, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 30 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; San Francisco, California, United States; Lexington, Kentucky, United States; Boston, Massachusetts, United States; Providence, Rhode Island, United States; Nashville, Tennessee, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.