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A Randomized, Multicenter, Multicountry Study to Evaluate the Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and to Evaluate the Relationship Between Florbetapir (18F) P

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Trial Conditions
  • Alzheimer's Disease
What is the purpose of this trial?

This study is designed to determine the effectiveness of florbetapir (18F) in changing patient management and to evaluate the association between scan status and cognitive decline.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
50  - 90 

Gender:
Both

Eligibility

Inclusion Criteria:

Patients may be enrolled in the mild impairment (not demented) group if the following
criteria are met:

1. Males or females ≥ 50 to <= 90 years of age.

2. Have cognitive decline verified by a study partner or cognitive impairment verified
by the study physician.

3. Have a study partner who provides separate consent and is willing to accompany the
patient on all of the study visits.

4. Have an MMSE score of 24 to 30 inclusive.

5. Can tolerate a 10-minute PET scan.

6. Have the ability to cooperate and comply with all study procedures.

7. 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.

8. Ability to provide informed consent for study procedures.

Patients may be enrolled in the dementia group if the following criteria are met:

1. Are males or females ≥ 50 to <= 90 years of age.

2. Meet clinical criteria for dementia.

3. Have a caregiver 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.

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.

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).

Exclusion Criteria:

Patients will be excluded from enrollment if they:

1. Have a current serious or unstable illness;

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, γ -secretase or β -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.

Patients will also be excluded from enrollment if their enrolling physician:

1. Does not consider Alzheimer's disease as a potential cause of the patient's cognitive
decline.

2. Is not the primary physician taking care of the patient with respect to the
management of their cognitive impairment.

3. Cannot categorize the patient as either: a) having a documented and completed
evaluation for cognitive decline within the past 18 months old; or b) currently
undergoing evaluation for cognitive decline.

4. Is unwilling to suspend all testing and other evaluation procedures between the time
of the baseline evaluation of the enrolling physician's diagnosis and management plan
and the time the completion of the PET scan.

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

Investigator Name:

  • Chief Medical Officer

Other Information

Sponsor: Avid Radiopharmaceuticals
Phase: Phase 4
Trial ID: NCT01703702
Volunteers:  Not Accepting Healthy Volunteers

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