AD01 Follow up Extension Visit | NCT01225809

Studies
AD01 Follow up Extension Visit

NCT01225809

Sponsor

Affiris AG

Status

Completed

Last Update Posted

Jan 26, 2011Estimated

Enrollment

17Actual

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

Jan 2011

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

Sep 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Oct 18, 2010

First Submission Date that Met QC Criteria

Oct 20, 2010

First Posted Date

Oct 21, 2010Estimated

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

Jan 25, 2011

Last Update Posted Date

Jan 26, 2011Estimated

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

Patients who were vaccinated with AFFITOPE AD01 during AFFiRiS001 will undergo a long-term follow-up period to get more information regarding the safety profile of AFFITOPE AD01.

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

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AD01with or without adjuvant		Patients who have received at least one immunization of AD01 with or without adjuvant during AFF001

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long term tolerability and safety of AFFITOPE AD01	retrospective assessment of safety data	One year.

Secondary Outcomes

Not provided

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 AFF003 and having received ≥1 vaccination with AFFITOPE AD01
Availability of a partner/caregiver knowing the patient

Exclusion Criteria:

Patients having received no vaccination with AFFITOPE AD01
History of questionable compliance to visit schedule

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 having participated in AFFiRiS 001 and AFF003 and having received ≥1 vaccination with AFFITOPE AD01

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Dal-Bianco, MD	Univ. Klinik für Neurologie	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univ. Klinik für Neurologie		Vienna		1090	Austria