Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006

NCT02008513 | Terminated Phase 2 DMC

• 2 other identifiers: AFF006A2012-005280-27
• Study Type: interventional
• Target: 194
• Locations: 6 countries
• Sites: 27

Brief Summary

This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.

Conditions

Alzheimer´s Disease

Keywords

AFFITOPE® AD02; Alzheimer Disease; Dementia; Brain Disease; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Mental Disorders

Outcome Measures

Primary Outcomes (1)

• Composite Measures of Primary Safety and Tolerability Endpoints

  * Withdrawal criteria * Number of Adverse events (AEs) * Number of any serious adverse events (SAE) * Alzheimer's Disease Assessment Scale - Cognition (ADAScog) * Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL)

  19 months

Secondary Outcomes (1)

• Composite Measures of Secondary Efficacy Endpoints

  19 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

AFF006 Placebo groups receive 6 AFFITOPE® AD02 vaccinations

Biological: AFFITOPE® AD02

Group 2

ACTIVE COMPARATOR

AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations

Biological: AFFITOPE® AD02; Biological: Placebo

Interventions

AFFITOPE® AD02 BIOLOGICAL

Group 1; Group 2

Placebo BIOLOGICAL

Group 2

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients having participated in AFF006+having received 6 investigational medicinal product (IMP) injections+having completed all visits
• Written informed consent
• Availability of a partner/caregiver
• Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.

You may not qualify if:

• Pregnant women.
• Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects.
• Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit 0.
• History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
• Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
• Contraindication for MRI imaging
• Presence and/or history of immunodeficiency (e.g., HIV infection).
• Prior and/or current treatment with experimental immunotherapeutics including Intravenous immunoglobulin (IVIG), AD antibody therapy and/or vaccines for AD except AD02.
• Prior and/or current treatment with immunosuppressive drugs.
• Treatment with benzodiazepines and/or nootropics administered at high doses and/or as newly started treatment.
• Treatment with anticholinergic drugs including Parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases.

Sponsors & Collaborators

• Affiris AG: lead

Study Sites (27)

Landeskrankenhaus Hall Gedächtnisambulanz

Hall in Tirol, 6060, Austria

Location

LNK Wagner-Jauregg, Dept. of geriatrics

Linz, 4020, Austria

Location

Christian Doppler Klinik, Univ. Klinik f. Neurologie

Salzburg, 5020, Austria

Location

MUW Klin. Pharmakologie und Klinik für Neurologie

Vienna, 1090, Austria

Location

MUW, Klin.Abt.f. Biolog. Psychiatrie

Vienna, 1090, Austria

Location

SMZ-Ost, Psychiatric Dep.

Vienna, 1220, Austria

Location

Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju

Rijeka, 51000, Croatia

Location

Opća bolnica Varaždin, Klinika za Neurologiju

Varaždin, 42000, Croatia

Location

"BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju

Zagreb, 10000, Croatia

Location

Psihijatrijska Bolnica Vrapče

Zagreb, 10090, Croatia

Location

University Thomayer Hospital

Prague, 14950, Czechia

Location

University Hospital Motol, Clinic of Neurology

Prague, 15006, Czechia

Location

CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard

Bordeaux, 33076, France

Location

Hôpital Neurologique Pierre Wertheimer

Bron, 69500, France

Location

Centre Hospitalier Universitaire (CHU) de Dijon

Dijon, 21033, France

Location

Centre Mémoire de Ressources et de Recherche, Service de Neurologie

Montpellier, 34295, France

Location

Hôpital de la Pitié-Salpêtrière

Paris, 75651, France

Location

CHU de Rennes Site Hôtel Dieu

Rennes, 35064, France

Location

Hopital La Grave

Toulouse, 31059, France

Location

Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie

Berlin, 14050, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie

Hamburg, 20251, Germany

Location

Arzneimittelforschung Leipzig GmbH, Studienzentrum

Leipzig, 04107, Germany

Location

Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie

Mannheim, 68159, Germany

Location

Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München

Munich, 81675, Germany

Location

Studienzentrum PD Dr. Steinwachs

Nuremberg, 90402, Germany

Location

NeuroPoint GmbH

Ulm/Donau, 89073, Germany

Location

EPAMED, s.r.o.

Košice, 04017, Slovakia

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Mental Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Neurocognitive Disorders

Study Officials

• Bruno Dubois, Prof.

  Centre des Maladies Cognitives et Comportementales, Federation des maladies du systeme nerveux, Hoptial de la Salpetriere, Pavillon Paul Castaignes (Sous-sol), 47-83 Bd de l'Hopital, 75651 Paris Cedex 13

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: December 11, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

DE (7); SL (1); CZ (2); CR (4); AU (6); FR (7)