Skip to main content
Delfa

← Trials/Trial dossier/NCT02031198

FUNDAMANT

CompletedPhase 1

18-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"

Asset

AADvac1

Listed sites

4

Recruiting sites

-

Enrollment

25

actual

Study population

Alzheimer’s disease

Key I/E criteria

Age 50-86MRI 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

Eudract number2013-004499-36
Org study IDAC-AD-002
NCT IDNCT02031198

Timeline

Milestones

Study start2014-01 (month precision)
Study first posted2014-01-09estimated
Primary completion2016-08actual (month precision)
Study completion2016-12actual (month precision)
Last update posted2017-03-17actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age86 Years
SexAll
Healthy volunteersNot accepted

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
Neuroimaging
1
Safety / tolerability / PK
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Patient cognition

Time frame:18+ months

ADAS-Cog

categorical status, descriptive

Neuroimaging

1 endpoint
Primary/protocol endpoint

Tolerability 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 endpoint
Secondary/protocol endpoint

Immunogenicity 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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.