Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects With Amnestic Mild Cognitive Impairment Who Will Convert to Clinically Probable Alzheimer's Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2014-01-31

Brief Summary

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This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from aMCI to a b-amyloid associated clinically probable Alzheimer's disease.

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Detailed Description

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Conditions

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Mild Cognitive Impairment Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Flutemetamol (18F) Injection

Group Type EXPERIMENTAL

Flutemetamol (18F) Injection

Intervention Type DRUG

All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.

Interventions

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Flutemetamol (18F) Injection

All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.

Intervention Type DRUG

Other Intervention Names

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Flutemetamol 18F

Eligibility Criteria

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Inclusion Criteria

* The subject is 60 years old or older.
* The subject meets the Petersen criteria for amnestic MCI.
* The subject has a score of less than or equal to 4 on the Modified Hachinski Ischemic Scale.
* The subject has a MMSE score of 24-30.
* The subject has a non-contrast MRI examination as part of the screening visit that excludes aMCI arising from structural causes.
* The subject and/or the subject's legally acceptable representative, if applicable, in accordance with local regulations, has signed and dated an informed consent.

Exclusion Criteria

* The subject has any significant neurologic disease other than suspected aMCI; such as Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities.
* The subject has one or more aneurysm clips, artificial heart valves, metal implants, embedded metal fragments or pacemakers that would pose a risk during an MRI.
* The subject has major depression, bipolar disorder, as described in the DSM-IV within the past year.
* The subject has history of schizophrenia (DSM-IV criteria).
* The subject has had, within the prior 3 months, psychotic features, agitation or behavioral problems that could lead to protocol compliance issues.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No