This is a study to evaluate a radioactive agent that helps to detect signs ofchanges in the brain, indicating reduced brain function in thinking.

• Conditions: Alzheimer's Disease; MedDRA version: 14.1Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-002595-13-IT
• Lead Sponsor: AVID RADIOPHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Dementia group: Are males or females = 50 to < 90 years of age; 2. Meet clinical criteria for dementia (i.e. cognitive decline that interferes with the ability to function at work or usual activities); 3. Have a caregiver (someone responsible for the patients well-being and has significant interaction with patient) who provides separate consent and is willing to accompany the patient on all of the study visits; 4. Have an MMSE score of 16 to 24 inclusive; 5. Have not received a clinical examination and/or laboratory test results that strongly indicates a non-neurodegenerative cause for the patients cognitive impairment; 6. Can tolerate a 10-minute PET scan. The Principal Investigator will carefully assess each patient and use sound medical judgment to determine whether the patient can tolerate the PET scan procedure; 7. Have the ability to cooperate and comply with all study procedures; 8. Have an enrolling physician who has less than high confidence in their diagnosis for the patient related to the cognitive decline at the time of enrollment. The level of confidence in the diagnosis should be rated by the physician as 85% or lower and should be interpreted as the physician estimating that their diagnosis will be correct in < 85% of patients with the same presentation as the patient; and 9. Ability to provide informed consent for study procedures (If the patient is incapable of giving informed consent, the patient's legal representative may consent on behalf of the patient but the patient must still confirm assent. This person may serve as the study partner as well).
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

1. Have a current serious or unstable illness that in the enrolling physician's opinion, could interfere with completion of the safety or efficacy evaluations included in this study, or has a life expectancy of less than one year; 2. The patient or enrolling physician knows the result of a previous amyloid imaging scan; 3. The patient has a known brain lesion, pathology or alternative diagnosis that strongly explains the patient's clinical presentation; 4. Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days; 5. Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, ? -secretase or ß -secretase inhibitor) unless it can be documented that the patient received only placebo during the course of the trial; 6. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or 7. 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 (negative urine ß-hCG at the time of screening and negative urine ß-hCG on the day of imaging) 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 florbetapir (18F).

Study & Design

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