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

Phase 2

Terminated

• Conditions: Alzheimer´s Disease
• Interventions: Biological: AFFITOPE® AD02; Biological: Placebo

• Registration Number: NCT02008513
• Lead Sponsor: Affiris AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

• 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.
• Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	AFFITOPE® AD02	AFF006 Placebo groups receive 6 AFFITOPE® AD02 vaccinations
Group 2	Placebo	AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations
Group 2	AFFITOPE® AD02	AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations

Primary Outcome Measures

Name	Time	Method
Composite Measures of Primary Safety and Tolerability Endpoints	19 months	* 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)

Secondary Outcome Measures

Name	Time	Method
Composite Measures of Secondary Efficacy Endpoints	19 months	* Clinical Dementia Rating Sum of Boxes (CDR-sb); * Free and Cued Selective Reminding Test (FCSRT); * Standard neuropsychological test battery (CogState); * Mini-Mental State Examination (MMSE); * Investigator's global evaluation scale (IGE); * CDR \[global aspects\]; * Neuropsychiatric Inventory (NPI) \[behavior\]; * quality of life (QOL) -AD

Trial Locations

Locations (27)

Opća bolnica Varaždin, Klinika za Neurologiju; 🇭🇷 Varaždin, Croatia

University Hospital Motol, Clinic of Neurology; 🇨🇿 Praha, Czech Republic

CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard; 🇫🇷 Bordeaux Cedex, France

Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie; 🇩🇪 Mannheim, Germany

Hôpital de la Pitié-Salpêtrière; 🇫🇷 Paris, France

Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie; 🇩🇪 Hamburg, Germany

SMZ-Ost, Psychiatric Dep.; 🇦🇹 Vienna, Austria

Hôpital Neurologique Pierre Wertheimer; 🇫🇷 Bron, France

Arzneimittelforschung Leipzig GmbH, Studienzentrum; 🇩🇪 Leipzig, Germany

Hopital La Grave; 🇫🇷 Toulouse, France

Christian Doppler Klinik, Univ. Klinik f. Neurologie; 🇦🇹 Salzburg, Austria

MUW, Klin.Abt.f. Biolog. Psychiatrie; 🇦🇹 Vienna, Austria

Psihijatrijska Bolnica Vrapče; 🇭🇷 Zagreb, Croatia

University Thomayer Hospital; 🇨🇿 Praha, Czech Republic

Centre Hospitalier Universitaire (CHU) de Dijon; 🇫🇷 Dijon, France

Studienzentrum PD Dr. Steinwachs; 🇩🇪 Nürnberg, Germany

MUW Klin. Pharmakologie und Klinik für Neurologie; 🇦🇹 Vienna, Austria

"BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju; 🇭🇷 Zagreb, Croatia

CHU de Rennes Site Hôtel Dieu; 🇫🇷 Rennes Cedex, France

Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München; 🇩🇪 Munich, Germany

NeuroPoint GmbH; 🇩🇪 Ulm/Donau, Germany

EPAMED, s.r.o.; 🇸🇰 Kosice, Slovakia

Landeskrankenhaus Hall Gedächtnisambulanz; 🇦🇹 Hall in Tirol, Austria

LNK Wagner-Jauregg, Dept. of geriatrics; 🇦🇹 Linz, Austria

Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju; 🇭🇷 Rijeka, Croatia

Centre Mémoire de Ressources et de Recherche, Service de Neurologie; 🇫🇷 Montpellier Cedex, France

Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie; 🇩🇪 Berlin, Germany