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Potential of Florbetapir F 18 PET to Inform Clinical Diagnosis and Management of Patients With Progressive Cognitive Decline

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Trial Conditions
  • Progressive Cognitive Decline
What is the purpose of this trial?

The study is designed to evaluate whether a florbetapir F 18 PET scan can impact clinical thinking when physicians are determining the likely cause of a subject's cognitive impairment.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
50 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Are one of the following:

1. 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).

2. Group B: Currently being evaluated for progressive cognitive decline with
further clinical or laboratory testing still planned.

- Have a site enrolling physician who has

1. less than high confidence in their diagnosis for the subject related to the
cognitive decline at the time of enrollment. The level of confidence in the
diagnosis should be rated by the physician as less than 85%, and should be
interpreted as the physician estimating that their diagnosis will be correct in
less than 85% of patients with the same presentation as the subject; and

2. suspicion that the subject's cognitive decline is caused, at least in part, by
Alzheimer's disease. The level of suspicion should be rated by the physician as
there being at least 15% of patients with the same presentation as the subject
would have Alzheimer's disease;

- 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).

Exclusion Criteria:

- 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 β-hCG at the time of
screening and negative urine β-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.

Gender: Both
Steward Physician(s)
  • Chief Medical Officer
Trial Interventions
Drug
  • florbetapir F 18
Physician Researcher

Investigator Name:

  • Chief Medical Officer

Other Information

Sponsor: Avid Radiopharmaceuticals
Phase: Phase 3
Trial ID: NCT01400425
Volunteers:  Not Accepting Healthy Volunteers

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