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Therapeutic Areas: Neurology | Family Medicine
Disease Category: Alzheimer's Disease
Location: United States, NC
Clinical Trial Details
Research Study Summary
Impact of Florbetapir F 18 PET on the Clinical Diagnosis and Management of Patients With Progressive Cognitive Decline
This study is designed to evaluate whether a florbetapir F 18 PET scan can effectively assist physicians in providing a diagnosis for the likely cause of the subject's progressive cognitive impairment.
Patient Inclusion Criteria:
- Are males or females ≥ 50 years of age;
- Are one of the following:
- Group A: Recently completed (within the past 18 months) a comprehensive clinical evaluation for progressive cognitive decline. A comprehensive clinical evaluation should include evidence of cognitive decline over six months, which may be aided by cognitive scales or neuropsychological testing, laboratory tests, and structural imaging such as magnetic resonance imaging (MRI) or computed tomography (CT).
- Group B: Currently being evaluated for progressive cognitive decline with further clinical or laboratory testing still planned.
- Have a site enrolling physician who has substantial uncertainty regarding their diagnosis at the time of enrollment, however, a diagnosis of Alzheimer's disease is considered at least one potential etiology for their cognitive decline;
- Can tolerate a 10 minute PET scan. The Principal Investigator will carefully assess each subject and use sound medical judgment to determine whether the subject can tolerate the PET scan procedure;
- Have the ability to cooperate and comply with all study procedures;
- Have a study partner willing to accompany the subject on all of the study visits; and
- Give informed consent for study procedures (If the subject is incapable of giving informed consent, the subject's designated decision maker may consent on behalf of the subject but the subject must still confirm assent. This person may serve as the study partner as well).
Patient Exclusion Criteria:
- Site enrolling physician has a high degree of certainty (> 85%) of the etiology of the subject's cognitive decline or dementia;
- Site enrolling physician has a high degree of certainty (> 85%) that Alzheimer's disease is not a diagnostic consideration; and
- Subject or site enrolling physician knows the result of a previous amyloid imaging scan.
- Are considered medically unstable;
- Require additional laboratory tests or workup between enrollment and completion of the florbetapir F 18 PET scan;
- Have a clinically significant infectious disease, including Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection;
- Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
- Have ever participated in an experimental study with an amyloid targeting agent unless it can be documented that the subject received only placebo during the course of the trial;
- Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
- 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 serum 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 F 18.
To Learn more
Both Male and Female
Date Last Changed:
July 19, 2013
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