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18-months Safety Follow-up Study of AADvac1, an Active Tau Vaccine for Alzheimer's Disease (FUNDAMANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02031198
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : March 17, 2017
Information provided by (Responsible Party):
Axon Neuroscience SE

Brief Summary:

This follow-up study continues to observe patients who have completed the phase 1 trial of AADvac1, for another 18 months.

Long-term safety and behavior of the immune response to AADvac1 over time are the main points of interest.

AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is the main constituent of neurofibrillary tangles (NFTs), and is intended to be a disease-modifying treatment for Alzheimer's disease, i.e. to halt its progress.

As this study is a Phase I study focused on tolerability and safety, efficacy will be assessed in an exploratory manner.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: AADvac1 Phase 1

Detailed Description:

AADvac1 is a candidate therapeutic vaccine for Alzheimer's disease that targets misfolded tau protein, a common denominator of neurofibrillary pathology. Based on preclinical results, the intervention is expected to reduce the number of neurofibrillary tangles, remove hyperphosphorylated tau protein and reduce the amount of oligomerized and insoluble pathological tau in the brain, to halt the spread of neurofibrillary pathology through the brain, and thus prevent associated cognitive decline.

The vaccine's antigenic determinant is a synthetic peptide derived from a tau protein sequence, which is coupled to keyhole limpet hemocyanin (KLH) and uses aluminum hydroxide (Alhydrogel) as an adjuvant.

At present AADvac1 is intended as an active immunotherapy for patients with diagnosed Alzheimer's disease (AD). According to need, patients will receive additional immunization doses beyond those administered in the preceding pase 1 trial; the raised titers of therapeutic antibodies and possible benefits of the treatment can extend beyond the duration of the study.

Because of the central role of pathological misfolded tau protein in the etiology of AD, the vaccine is expected to be more effective than active or passive immunotherapies aiming to eliminate the amyloid β plaques that have been clinically investigated so far.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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"
Study Start Date : January 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: AADvac1

Patients who have received 6 doses in the previous trial will be administered 1-2 booster doses of AADvac1 (2 if their antibody titers decline below those achieved in the previous trial).

Patients who have received 3 doses in the previous trial will be administered another 3 doses, then vaccinated with booster doses as above.

Drug: AADvac1
Active immunization against pathological Alzheimer's disease tau protein
Other Names:
  • Axon peptide 108 (coupled to KLH), 40ug/0.3mL
  • Axon peptide 108 conjugated to KLH

Primary Outcome Measures :
  1. 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 ]

    Safety is assessed via recording of all Adverse Events and Adverse Events

    Patients are observed via:

    MRI Clinical & neuro-psychiatric observation Cognitive testing ECG Blood biochemistry, hematology, coagulation measurement Urine analysis

Secondary Outcome Measures :
  1. Immunogenicity of AADvac1 [ Time Frame: Immune response to the vaccine will be assessed over 18 month ]

    Measurement of:

    Titres of antibodies reactive with AADvac1 Titres of antibodies reactive with Alzheimer tau protein Antibody isotype profiles

  2. Patient cognition [ Time Frame: 18+ months ]

    Tests used:

    ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) COWAT (Controlled oral word association test) Category fluency

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031198

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Medizinische Universitat Graz
Graz, Steiermark, Austria, 8036
Univeristätsklinik für Neurologie, PMU, Christian-Doppler Klinik
Salzburg, Austria, 5020
Medizinische Universitat Wien
Wien, Austria, 1090
Sozialmedizinisches Zentrum Ost (SMZ Ost) /Donauspital, Memory Clinic and Karl Landsteiner Institut for Amnestic disorders
Wien, Austria, A-1220
Sponsors and Collaborators
Axon Neuroscience SE
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Principal Investigator: Reinhold Schmidt, Professor Medizinische Universität Graz
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Axon Neuroscience SE
ClinicalTrials.gov Identifier: NCT02031198    
Other Study ID Numbers: AC-AD-002
2013-004499-36 ( EudraCT Number )
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017
Keywords provided by Axon Neuroscience SE:
Alzheimer's disease
disease modifying
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders