NCT00711139

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

May 27, 2010

Status Verified

December 1, 2009

Enrollment Period

1.4 years

First QC Date

July 4, 2008

Last Update Submit

May 26, 2010

Conditions

Alzheimer's Disease

Keywords

AlzheimerMorbus AlzheimerAlzheimer VaccineVaccineADA-beta immunotherapy

Outcome Measures

Primary Outcomes (1)

  • Tolerability

    1 year

Secondary Outcomes (1)

  • Immunological and clinical efficacy (evaluated in an explorative manner only)

    1 year

Study Arms (2)

1

AFFITOPE AD01

2

AFFITOPE AD01 + Adjuvant

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Markus Mueller, Univ. Prof.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 4, 2008

First Posted

July 8, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

May 27, 2010

Record last verified: 2009-12

Locations

AU(1)