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

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ClinicalTrials.gov Identifier: NCT01117818
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
Affiris AG

Study Description
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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.
Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
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:
  • placebo
  • control


Outcome Measures
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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 ]

Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01117818


Locations
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Sponsors and Collaborators
Affiris AG
Investigators
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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
More Information
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Responsible Party: Affiris AG
ClinicalTrials.gov 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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders