Long-term Safety and Tolerability of AFFITOPE AD01 | NCT00711139

Studies
Long-term Safety and Tolerability of AFFITOPE AD01

NCT00711139

Sponsor

Affiris AG

Status

Completed

Last Update Posted

May 27, 2010Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

Alzheimer's Disease

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT 2008-001455-22

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Jul 4, 2008

First Submission Date that Met QC Criteria

Jul 7, 2008

First Posted Date

Jul 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2010

Last Update Posted Date

May 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE AD01 applied during AFFiRiS 001

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		AFFITOPE AD01
2		AFFITOPE AD01 + Adjuvant

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tolerability		1 year

Secondary Outcomes

Measure	Description	Time Frame
Immunological and clinical efficacy (evaluated in an explorative manner only)		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent signed and dated by the patient or the patient's legal representative and the caregiver
Patients having participated in AFFiRiS 001 and received at least 1 vaccination with AFFITOPE AD01
Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits.

Exclusion Criteria:

Patients having received no vaccination with AFFITOPE AD01
Contraindication for MRI imaging
History of questionable compliance to visit schedule, patients not expected to complete the clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects having participated in AFFiRiS 001, as AFFiRiS 003 is a follow-up trial.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Markus Mueller, Univ. Prof.	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Pharmacology, Medical University of Vienna		Vienna		1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided