Trial record 9 of 12 for:
affiris
Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Affiris AG
Information provided by (Responsible Party):
Affiris AG
ClinicalTrials.gov Identifier:
NCT01117818
First received: April 19, 2010
Last updated: June 8, 2012
Last verified: June 2012
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Purpose
This is a multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80 years. Approximately 40 study sites in Europe will be involved. Patients will be randomized to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Biological: active: AFFITOPE AD02 Biological: control: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Controlled, Parallel Group, Double-blind, Multi-center, Phase II Study to Assess the Clinical- and Immunological Activity,as Well as the Safety and Tolerability of Different Doses/Formulations of AFFITOPE AD02 Administered Repeatedly to Patients With Early Alzheimer's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Affiris AG:
Primary Outcome Measures:
- cognitive(ADAS-cog modified) and functional(ADCS-ADL modified) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A: AFFITOPE AD02 |
Biological: active: AFFITOPE AD02
vaccination
Other Name: AFFITOPE AD02
|
| Active Comparator: B: AFFITOPE AD02 |
Biological: active: AFFITOPE AD02
vaccination
Other Name: AFFITOPE AD02
|
| Active Comparator: C: AFFITOPE AD02 |
Biological: active: AFFITOPE AD02
vaccination
Other Name: AFFITOPE AD02
|
| Active Comparator: D: Placebo control |
Biological: control: Placebo
vaccination
Other Names:
|
Detailed Description:
AFFITOPE AD02 is a second generation AD immunotherapeutics targeting Aβ. Its active component is a synthetic peptide functionally mimicking the unmodified N-terminus of Aβ.
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed consent capability
- Early AD, based on episodic memory deficit and hippocampal atrophy
- Age from 50 to 80, inclusive
- MMSE of 20+
- Brain magnetic resonance imaging scan consistent with the diagnosis of AD
- Stable doses of medications (cholinesterase inhibitors and memantine allowed)
- Caregiver able to attend all visits with patient
Exclusion Criteria:
- Significant neurological disease other than AD
- Major psychiatric illness
- Significant systemic illness
- Autoimmune disease
- Prior treatment with experimental immunotherapeutics for AD including IVIG
- Women of childbearing potential without birth control
- Contraindication for MRI scan
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117818
Locations
| Austria | |
| Landeskrankenhaus Hall Gedächtnisambulanz | |
| Hall in Tirol, Austria, 6060 | |
| LNK Wagner-Jauregg, Dept. of geriatrics | |
| Linz, Austria, 4020 | |
| Christian Doppler Klinik, Univ. Klinik f. Neurologie | |
| Salzburg, Austria, 5020 | |
| SMZ-Ost, Psychiatric Dep. | |
| Vienna, Austria, 1220 | |
| MUW Klin. Pharmakologie und Klinik für Neurologie | |
| Vienna, Austria, 1090 | |
| MUW, Klin.Abt.f. Biolog. Psychiatrie | |
| Vienna, Austria, 1090 | |
| Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt | |
| Vienna, Austria, 1080 | |
| Croatia | |
| Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju | |
| Rijeka, Croatia, 51000 | |
| Opća bolnica Varaždin, Klinika za Neurologiju | |
| Varaždin, Croatia, 42000 | |
| Psihijatrijska Bolnica Vrapče | |
| Zagreb, Croatia, 10090 | |
| Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju | |
| Zagreb, Croatia, 10000 | |
| "BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| University Thomayer Hospital | |
| Praha 4, Czech Republic, 149 50 | |
| University Hospital Motol, Clinic of Neurology | |
| Praha 5, Czech Republic, 150 06 | |
| France | |
| CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard | |
| Bordeaux Cedex, France, 33076 | |
| Hôpital Neurologique Pierre Wertheimer | |
| Bron, France, 69500 | |
| Centre Hospitalier Universitaire (CHU) de Dijon | |
| Dijon, France, 21033 | |
| Centre Mémoire de Ressources et de Recherche, Service de Neurologie | |
| Montpellier Cedex 05, France, 34295 | |
| Hôpital de la Pitié-Salpêtrière | |
| Paris, France, 75651 | |
| CHU de rennes Site Hôtel Dieu | |
| RENNES Cedex, France, 35064 | |
| Hopital La Grave | |
| Toulouse, France, 31059 | |
| Germany | |
| Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie | |
| Berlin, Germany, 14050 | |
| Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie | |
| Hamburg, Germany, 20251 | |
| Arzneimittelforschung Leipzig GmbH, Studienzentrum | |
| Leipzig, Germany, 04107 | |
| Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie | |
| Mannheim, Germany, 68159 | |
| Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München | |
| Munich, Germany, 81675 | |
| Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie | |
| Nürnberg, Germany, 90419 | |
| Studienzentrum PD Dr. Steinwachs | |
| Nürnberg, Germany, 90402 | |
| NeuroPoint GmbH | |
| Ulm/Donau, Germany, 89073 | |
| Slovakia | |
| EPAMED, s.r.o. | |
| Kosice, Slovakia, 040 17 | |
| Psychiatric Hospital Michalovce | |
| Michalovce, Slovakia, 071 01 | |
Sponsors and Collaborators
Affiris AG
Investigators
| Principal Investigator: | 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 |
More Information
No publications provided
| Responsible Party: | Affiris AG |
| ClinicalTrials.gov Identifier: | NCT01117818 History of Changes |
| Other Study ID Numbers: | AFF006, 2009-016504-22 |
| Study First Received: | April 19, 2010 |
| Last Updated: | June 8, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013