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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01117818
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : December 11, 2013
Information provided by (Responsible Party):
Affiris AG

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Biological: active: AFFITOPE AD02 Biological: control: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A: AFFITOPE AD02 Biological: active: AFFITOPE AD02
Other Name: AFFITOPE AD02

Active Comparator: B: AFFITOPE AD02 Biological: active: AFFITOPE AD02
Other Name: AFFITOPE AD02

Active Comparator: C: AFFITOPE AD02 Biological: active: AFFITOPE AD02
Other Name: AFFITOPE AD02

Active Comparator: D: Placebo control Biological: control: Placebo
Other Names:
  • placebo
  • control

Primary Outcome Measures :
  1. cognitive(ADAS-cog modified) and functional(ADCS-ADL modified) [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI) [ Time Frame: 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01117818

Show Show 31 study locations
Sponsors and Collaborators
Affiris AG
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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
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Responsible Party: Affiris AG Identifier: NCT01117818    
Other Study ID Numbers: AFF006
2009-016504-22 ( EudraCT Number )
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders