A diagnostic marker to visualize Alzheimer pathology using a PET scan.

• Conditions: Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; nselected patient population subjects visiting the memory clinic of the VUmc Alzheimer center.

• Registration Number: EUCTR2014-000562-21-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-05
• Last Update Posted: 12 January 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients of the VUmc Alzheimer Center with a written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion Criteria

Patients who
- are considered medically unstable (assessed by physician);
- require additional laboratory tests or workup between enrollment and completion of the [18F]FBB PET scan;
- are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant or breast feeding at screening. Females must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods such as prescribed birth control or IUD for 24 hours following administration of [18F]FBB;
- are not able to give informed consent (personally or via authorized person) for whatever reason.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified