NCT00633841

Brief Summary

The purpose of this study is to assess the tolerability and safety of repeated subcutaneous injection of a single dose of AFFITOPE AD02 in patients with mild to moderate Alzheimer's Disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 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

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 19, 2010

Status Verified

October 1, 2010

Enrollment Period

1.6 years

First QC Date

March 5, 2008

Last Update Submit

October 18, 2010

Conditions

Alzheimer's Disease

Keywords

AlzheimerMorbus AlzheimerAlzheimer VaccineVaccineADAβ immunotherapy

Outcome Measures

Primary Outcomes (1)

  • Tolerability

    1 year

Secondary Outcomes (1)

  • Immunological and clinical efficacy (evaluated in explorative manner)

    1 year

Study Arms (2)

1

ACTIVE COMPARATOR

AFFITOPE AD02 without adjuvant

Biological: AFFITOPE AD02

2

ACTIVE COMPARATOR

AFFITOPE AD02 with adjuvant

Biological: AFFITOPE AD02

Interventions

AFFITOPE AD02BIOLOGICAL

4 subcutaneous injections of IP in 4-week intervals

12

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of probable Alzheimer's disease based on the NINCDS/ADRDA criteria.
  • Alzheimer's disease of mild to moderate degree (MMSE 16-26)
  • Magnetic Resonance Imaging scan (MRI) of brain consistent with diagnosis of AD.
  • Written informed consent signed and dated by the patient and the caregiver.
  • Age 50-80 years.
  • Availability of a partner/caregiver

You may not qualify if:

  • Presence or history of allergy to components of the vaccine.
  • Contraindication for MRI imaging.
  • Participation in another clinical trial.
  • Prior and/or current treatment with experimental immunotherapeutics including IVIG or vaccines for AD.
  • Prior and/or current treatment with immunosuppressive drugs
  • History and/or presence of autoimmune disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordination Univ. Doz. Dr. Margot Schmitz

Vienna, A-1010, Austria

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Margot Schmitz, Univ. Doz. Dr.

    Ordination Univ. Doz. Dr. Margot Schmitz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 12, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 19, 2010

Record last verified: 2010-10

Locations

AU(1)