Observational Follow-up Extension Study of AFF002 and AFF... | NCT01357629

Studies
Observational Follow-up Extension Study of AFF002 and AFF004A in Patients With Alzheimer's Disease

NCT01357629

Sponsor

Affiris AG

Status

Terminated

Last Update Posted

Dec 11, 2013Estimated

Enrollment

11Actual

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

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The Study could not be done for every potential participant as planned in the protocol for organizational reasons.

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Apr 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Mar 21, 2011

First Submission Date that Met QC Criteria

May 20, 2011

First Posted Date

May 23, 2011Estimated

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

Dec 10, 2013

Last Update Posted Date

Dec 11, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study examines the long term Safety Follow-up of first patients vaccinated with AD02.

Detailed Description

Patients who have received AD02 during AFF002 and AFF004A will be observed.

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

11Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety	collection and evaluation of AEs, SAEs	up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

participation in AFF002 and AFF004A

Exclusion Criteria:

no vaccination with AD02

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with Alzheimer´s Disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Achim Schneeberger, MD	Sponsor GmbH	Study Director
Siegfried Kasper, MD	Medical University Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Studienzentrum der PROSENEX Ambulatoriumsbetriebs GmbH		Vienna	State of Vienna	1080	Austria
Univ. Klinik für Psychiatire und Psychotherapie