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Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
active: AFFITOPE AD02
control: Placebo
Sponsored by
Affiris AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Landeskrankenhaus Hall Gedächtnisambulanz
  • LNK Wagner-Jauregg, Dept. of geriatrics
  • Christian Doppler Klinik, Univ. Klinik f. Neurologie
  • Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt
  • MUW Klin. Pharmakologie und Klinik für Neurologie
  • MUW, Klin.Abt.f. Biolog. Psychiatrie
  • SMZ-Ost, Psychiatric Dep.
  • Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju
  • Opća bolnica Varaždin, Klinika za Neurologiju
  • "BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju
  • Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju
  • Psihijatrijska Bolnica Vrapče
  • University Thomayer Hospital
  • University Hospital Motol, Clinic of Neurology
  • CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard
  • Hôpital Neurologique Pierre Wertheimer
  • Centre Hospitalier Universitaire (CHU) de Dijon
  • Centre Mémoire de Ressources et de Recherche, Service de Neurologie
  • Hôpital de la Pitié-Salpêtrière
  • CHU de rennes Site Hôtel Dieu
  • Hopital La Grave
  • Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie
  • Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie
  • Arzneimittelforschung Leipzig GmbH, Studienzentrum
  • Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie
  • Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München
  • Studienzentrum PD Dr. Steinwachs
  • Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie
  • NeuroPoint GmbH
  • EPAMED, s.r.o.
  • Psychiatric Hospital Michalovce

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

A: AFFITOPE AD02

B: AFFITOPE AD02

C: AFFITOPE AD02

D: Placebo control

Arm Description

Outcomes

Primary Outcome Measures

cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)

Secondary Outcome Measures

cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)

Full Information

First Posted
April 19, 2010
Last Updated
December 10, 2013
Sponsor
Affiris AG
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1. Study Identification

Unique Protocol Identification Number
NCT01117818
Brief Title
Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiris AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
335 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: AFFITOPE AD02
Arm Type
Active Comparator
Arm Title
B: AFFITOPE AD02
Arm Type
Active Comparator
Arm Title
C: AFFITOPE AD02
Arm Type
Active Comparator
Arm Title
D: Placebo control
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
active: AFFITOPE AD02
Other Intervention Name(s)
AFFITOPE AD02
Intervention Description
vaccination
Intervention Type
Biological
Intervention Name(s)
control: Placebo
Other Intervention Name(s)
placebo, control
Intervention Description
vaccination
Primary Outcome Measure Information:
Title
cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Dubois, Prof
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landeskrankenhaus Hall Gedächtnisambulanz
City
Hall in Tirol
ZIP/Postal Code
6060
Country
Austria
Facility Name
LNK Wagner-Jauregg, Dept. of geriatrics
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Christian Doppler Klinik, Univ. Klinik f. Neurologie
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt
City
Vienna
ZIP/Postal Code
1080
Country
Austria
Facility Name
MUW Klin. Pharmakologie und Klinik für Neurologie
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
MUW, Klin.Abt.f. Biolog. Psychiatrie
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
SMZ-Ost, Psychiatric Dep.
City
Vienna
ZIP/Postal Code
1220
Country
Austria
Facility Name
Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Opća bolnica Varaždin, Klinika za Neurologiju
City
Varaždin
ZIP/Postal Code
42000
Country
Croatia
Facility Name
"BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Psihijatrijska Bolnica Vrapče
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
Facility Name
University Thomayer Hospital
City
Praha 4
ZIP/Postal Code
149 50
Country
Czech Republic
Facility Name
University Hospital Motol, Clinic of Neurology
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Neurologique Pierre Wertheimer
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
Centre Hospitalier Universitaire (CHU) de Dijon
City
Dijon
ZIP/Postal Code
21033
Country
France
Facility Name
Centre Mémoire de Ressources et de Recherche, Service de Neurologie
City
Montpellier Cedex 05
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital de la Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU de rennes Site Hôtel Dieu
City
RENNES Cedex
ZIP/Postal Code
35064
Country
France
Facility Name
Hopital La Grave
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Arzneimittelforschung Leipzig GmbH, Studienzentrum
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Facility Name
Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Studienzentrum PD Dr. Steinwachs
City
Nürnberg
ZIP/Postal Code
90402
Country
Germany
Facility Name
Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
NeuroPoint GmbH
City
Ulm/Donau
ZIP/Postal Code
89073
Country
Germany
Facility Name
EPAMED, s.r.o.
City
Kosice
ZIP/Postal Code
040 17
Country
Slovakia
Facility Name
Psychiatric Hospital Michalovce
City
Michalovce
ZIP/Postal Code
071 01
Country
Slovakia

12. IPD Sharing Statement

Learn more about this trial

Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease

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