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Trial record 3 of 190 for:    tau antibody

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
Sponsor:
Information provided by (Responsible Party):
Axon Neuroscience SE

Tracking Information
First Submitted Date  ICMJE January 7, 2014
First Posted Date  ICMJE January 9, 2014
Last Update Posted Date March 17, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18-months Safety Follow-up Study of AADvac1, an Active Tau Vaccine for Alzheimer's Disease
Official Title  ICMJE 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"
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Drug: AADvac1
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2015)
25
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2014)
30
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 86 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02031198
Other Study ID Numbers  ICMJE AC-AD-002
2013-004499-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Axon Neuroscience SE
Study Sponsor  ICMJE Axon Neuroscience SE
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Reinhold Schmidt, Professor Medizinische Universität Graz
PRS Account Axon Neuroscience SE
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP