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FUNDAMANT
CompletedPhase 118-months Safety Follow-up Study of AADvac1, an Active Tau Vaccine for Alzheimer's Disease
An 18-months Open Label Phase I Follow-up Study on Patients With Alzheimer's Disease Who Have Completed the AADvac1 Phase I Study "AXON CO 18700"
Lead sponsor
Asset
AADvac1
Listed sites
4
Recruiting sites
-
Enrollment
25
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Age 50-86•MRI contraindications excluded
Primary endpoint
•Tolerability and safety profile of AADvac1
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Completion of visit V8 of the AADvac1 phase I study AXON CO 18700 (EUDRACT 2012-003916-29).
2. Informed consent capability (as determined by an independent neurologist/psychiatrist).
3. Written informed consent signed and dated by the patient and the caregiver.
4. Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits
5. Adequate visual and auditory abilities and language skills to allow neuropsychological testing.
6. Female patients are only eligible for the study if they are either surgically sterile or at least 2 years postmenopausal.
7. Sexually active males must be using reliable contraception methods (i.e. condoms) or be surgically sterile
Exclusion criteria
1. Pregnant women.
2. Participation in another clinical trial during the course of this study.
3. Contraindication for MRI imaging such as MRI-incompatible metallic endoprosthesis or MRI-incompatible stent implantation
4. History and/or presence of autoimmune disease, if considered relevant by the investigator.
5. Significant systemic illness (e.g., chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, congenital long QT syndrome, other deficiencies), if considered relevant by the investigator.
6. Current treatment with immunosuppressive drugs.
Endpoints (3)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
1 endpointPatient cognition
Time frame:18+ months
ADAS-Cog
categorical status, descriptive
Neuroimaging
1 endpointTolerability and safety profile of AADvac1 in patients with mild-to-moderate Alzheimer's disease
Time frame:Tolerability & safety are assessed over a period of 18+ months
event count, event
Safety / tolerability / PK
1 endpointImmunogenicity of AADvac1
Time frame:Immune response to the vaccine will be assessed over 18 month
descriptive
Publications (2)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID30355322via DERIVED
- PMID27955995via DERIVED
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.