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

NCT02031198 | Completed Phase 1 DMC

• 2 other identifiers: AC-AD-0022013-004499-36
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; tau; dementia; elderly; cognitive; disease modifying; treatment; immunization; vaccine

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (2)

• Immunogenicity of AADvac1

  Immune response to the vaccine will be assessed over 18 month

• Patient cognition

  18+ months

Study Arms (1)

AADvac1

EXPERIMENTAL

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

Interventions

AADvac1 DRUG

Active immunization against pathological Alzheimer's disease tau protein

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

AADvac1

Eligibility Criteria

• Age: 50 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Axon Neuroscience SE: lead

Study Sites (4)

Univeristätsklinik für Neurologie, PMU, Christian-Doppler Klinik

Salzburg, Salzburg, 5020, Austria

Location

Medizinische Universitat Graz

Graz, Styria, 8036, Austria

Location

Medizinische Universitat Wien

Vienna, Vienna, 1090, Austria

Location

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

Vienna, Vienna, A-1220, Austria

Location

Related Publications (2)

• 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.

  PMID: 30355322 DERIVED

• 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.

  PMID: 27955995 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Pick Disease of the Brain; Dementia

Interventions

AADvac1

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Study Officials

• Reinhold Schmidt, Professor

  Medizinische Universität Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 17, 2017

Record last verified: 2017-03

Locations

AU (4)