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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Affiris AG
ClinicalTrials.gov Identifier:
NCT01117818
First received: April 19, 2010
Last updated: December 10, 2013
Last verified: December 2013

April 19, 2010
December 10, 2013
September 2010
December 2013   (final data collection date for primary outcome measure)
cognitive(ADAS-cog modified) and functional(ADCS-ADL modified) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
cognitive(ADAS-cog modified) and functional(ADCS-ADL modified) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01117818 on ClinicalTrials.gov Archive Site
cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Biological: active: AFFITOPE AD02
    vaccination
    Other Name: AFFITOPE AD02
  • Biological: control: Placebo
    vaccination
    Other Names:
    • placebo
    • control
  • Active Comparator: A: AFFITOPE AD02
    Intervention: Biological: active: AFFITOPE AD02
  • Active Comparator: B: AFFITOPE AD02
    Intervention: Biological: active: AFFITOPE AD02
  • Active Comparator: C: AFFITOPE AD02
    Intervention: Biological: active: AFFITOPE AD02
  • Active Comparator: D: Placebo control
    Intervention: Biological: control: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
335
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Croatia,   Czech Republic,   France,   Germany,   Slovakia
 
NCT01117818
AFF006, 2009-016504-22
Yes
Affiris AG
Affiris AG
Not Provided
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
Affiris AG
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP