Determine the value of the compound [18F]-AV45, which is usable for visualization of the build-up of the amyloid protein in brains of memory clinic patients, in making a diagnosis in patients of the memory outpatient clinic.

Phase 1

• Conditions: The total number of inclusion in this study is 170 subjects; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; 140 patients (including Alzheimer’s disease (AD) patients, patients with mild cognitive impairment (MCI), patients with subjective memory complaints (SMC), patients with other neurodegenerative diseases and 30 cognitively normal volunteers.

• Registration Number: EUCTR2012-001599-12-NL
• Lead Sponsor: VU University Medical Center (VUmc)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-17
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Written informed consent; - weight >50 kg; - Mini Mental State Examination score = 18.
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 140
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Patients who
1. Have a current clinically significant psychiatric condition that neurologists/geriatricians feel would preclude the ability to have a research PET scan;
2. Have Acquired Immune Deficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV);
3. Are women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Women of childbearing potential must not be pregnant (negative urine ß-hCG at the time of screening and negative urine ß-hCG on the day of imaging) or breast feeding at screening. Women 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 florbetapir (18F);
4. Have a relevant history of severe drug allergy or hypersensitivity (relevant severe drug allergies should be determined by the Principal Investigator or Co-Principal Investigator, and any questions about a subject’s eligibility can be directed to Avid Radiopharmaceuticals Inc. If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study with a novel compound);
5. Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, ?-secretase or ?-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial;
6. Have donated blood within 3 months prior to the florbetapir (18F) PET scan day;
7. Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
8. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.

Study & Design

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