NCT01093664

Brief Summary

This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who have received the vaccine within the clinical study AFF002.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2009

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

First Submitted

Initial submission to the registry

September 2, 2009

Completed
29 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 19, 2010

Status Verified

October 1, 2010

Enrollment Period

9 months

First QC Date

September 2, 2009

Last Update Submit

October 18, 2010

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    * Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal * Adverse events (AEs) * Serious adverse events (SAEs) * Physical and neurological examination * Concomitant medication * Vital signs (blood pressure, heart rate, respiratory rate, body temperature) * Body mass (weight and height) * MRI of brain * ECG * Laboratory assessment (haematology, biochemistry, coagulation, serology and urinalysis)

    July 2010

Secondary Outcomes (1)

  • Immunological and clinical activity

    July 2010

Study Arms (1)

AFFITOPE AD02

EXPERIMENTAL
Biological: AFFITOPE AD02

Interventions

AFFITOPE AD02BIOLOGICAL

s.c. injection

AFFITOPE AD02

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participation in AFF002 and AFF004

You may not qualify if:

  • Presence or history of allergy to components of the vaccine, if considered relevant by the investigator
  • Contraindication for MRI imaging
  • History and/or presence of autoimmune disease, if considered relevant by the investigator
  • Active infectious disease (e.g., Hepatitis B, C)
  • Presence and/or history of Immunodeficiency (e.g., HIV)
  • Significant systemic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordination Schmitz

Vienna, Vienna, 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.

    Ordination Schmitz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2009

First Posted

March 26, 2010

Study Start

October 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

October 19, 2010

Record last verified: 2010-10

Locations

AU(1)