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Alzheimer's DiseasePhase 1FUNDAMANTNCT02031198

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

A Phase 1 study testing AADvac1 in people with Alzheimer's Disease, run by Axon Neuroscience SE at 4 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 86 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
AADvac1
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
4 sitesAustria
Study dates
Jan 2014to Dec 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 86 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Completion of visit V8 of the AADvac1 phase I study AXON CO 18700 (EUDRACT 2012-003916-29).
  • Informed consent capability (as determined by an independent neurologist/psychiatrist).
  • Written informed consent signed and dated by the patient and the caregiver.
  • Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits
  • Adequate visual and auditory abilities and language skills to allow neuropsychological testing.
  • Female patients are only eligible for the study if they are either surgically sterile or at least 2 years postmenopausal.
  • Sexually active males must be using reliable contraception methods (i.e. condoms) or be surgically sterile.

Who cannot join

  • Pregnant women.
  • Participation in another clinical trial during the course of this study.
  • Contraindication for MRI imaging such as MRI-incompatible metallic endoprosthesis or MRI-incompatible stent implantation
  • History and/or presence of autoimmune disease, if considered relevant by the investigator.
  • 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.
  • Current treatment with immunosuppressive drugs.

Trial locations and contacts

4 sites in 1 country.

Austria4 sites

  • Medizinische Universitat Graz

    Graz, Styria, 8036

  • Univeristätsklinik für Neurologie, PMU, Christian-Doppler Klinik

    Salzburg, State of Salzburg, 5020

  • Medizinische Universitat Wien

    Vienna, State of Vienna, 1090

  • Sozialmedizinisches Zentrum Ost (SMZ Ost) /Donauspital, Memory Clinic and Karl Landsteiner Institut for Amnestic disorders

    Vienna, State of Vienna, A-1220

Other trials in Austria

About this study

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"

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.

Read the 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.

Being tested
AADvac1
Keywords
Alzheimer's disease, tau, dementia, elderly, cognitive, disease modifying, treatment, immunization, vaccine
Medical subject headings
Alzheimer Disease, Pick Disease of the Brain, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AADvac1Drug

    Also called Axon peptide 108 (coupled to KLH), 40ug/0.3mL, Axon peptide 108 conjugated to KLH

    Active immunization against pathological Alzheimer's disease tau protein

Study groups in NCT02031198
Study groupRoleWhat they receive
AADvac1ExperimentalPatients 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.
Receives: Drug: AADvac1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerability and safety profile of AADvac1 in patients with mild-to-moderate Alzheimer's disease

    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

    Measured: Tolerability & safety are assessed over a period of 18+ months

Secondary outcomes (2)

  1. Immunogenicity of AADvac1

    Measurement of:

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

    Measured: Immune response to the vaccine will be assessed over 18 month

  2. Patient cognition

    Tests used:

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

    Measured: 18+ months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionAug 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02031198
Sponsor's protocol ID
AC-AD-002
Other IDs
2013-004499-36
Acronym
FUNDAMANT
Status last verified
Mar 2017
First submitted
7 Jan 2014
Last updated
17 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Novak P, Schmidt R, Kontsekova E, Kovacech B, Smolek T, Katina S, Fialova L, Prcina M, Parrak V, Dal-Bianco P, Brunner M, Staffen W, Rainer M, Ondrus M, Ropele S, Smisek M, Sivak R, Zilka N, Winblad B, Novak M. FUNDAMANT: an interventional 72-week phase 1 follow-up study of AADvac1, an active immunotherapy against tau protein pathology in Alzheimer's disease. Alzheimers Res Ther. 2018 Oct 24;10(1):108. doi: 10.1186/s13195-018-0436-1.

    PubMed 30355322

  • Novak P, Schmidt R, Kontsekova E, Zilka N, Kovacech B, Skrabana R, Vince-Kazmerova Z, Katina S, Fialova L, Prcina M, Parrak V, Dal-Bianco P, Brunner M, Staffen W, Rainer M, Ondrus M, Ropele S, Smisek M, Sivak R, Winblad B, Novak M. Safety and immunogenicity of the tau vaccine AADvac1 in patients with Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Neurol. 2017 Feb;16(2):123-134. doi: 10.1016/S1474-4422(16)30331-3. Epub 2016 Dec 10.

    PubMed 27955995

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AADvac1 in people with Alzheimer's Disease, run by Axon Neuroscience SE at 4 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02031198, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.

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