To test the effectiveness of florbetapir (18F) as a diagnostic tool in subjects particpiating in the IRCCS-FBF protocol

• Conditions: Alzheimer's disease and other neurodegenerative diseases, as for example Dementia with Lewy bodies, Parkinson Dementia, Vascular Dementia and Tau Protein associated Dementia.; MedDRA version: 14.1Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-003079-20-IT
• Lead Sponsor: AVID RADIOPHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-28
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects should have already met inclusion and exclusion criteria for the main protocol Clinical assessment and follow-up of a naturalistic population of patients enrolled in an amyloid imaging program in Memory Clinics in Brescia, Italy”, that are: a) Patients with cognitive complaints who will be included in a diagnostic work-up to make a differential diagnosis; b) Age between 50 and 85 years; c) Patients who have an informant (spouse, adult child, or friend who knows the patient well) available for accompanying to visits. In addition: Subjects meet the following inclusion criteriona: 1. Subjects who sign an Independent Ethics Committee (IEC) approved informed consent form prior to any florbetapir (18F) PET procedures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

Subjects will be excluded from enrollment if they have already met exclusion criteria for the main protocol Clinical assessment and follow-up of a naturalistic population of patients enrolled in an amyloid imaging program in Memory Clinics in Brescia, Italy”, that are: • Are MCI patients with a CDR (Clinical Dementia rating Scale) > 0,5 at baseline; AD and non-AD patients with a CDR (Clinical Dementia rating Scale) > 2 at baseline. In addition, subjects will be excluded from enrollment if they: : a. Have a current clinically significant psychiatric condition that neurologists/geriatricians feel would preclude the ability to have a research PET scan; b. 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); c. 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); d. 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; f. Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days; and g. 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