Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Medpace, Inc.
i3 Statprobe
i3 Research
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01028053
First received: December 7, 2009
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment
Alzheimer's Disease
 Drug: Flutemetamol (18F) Injection
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Principal Open-label Study to 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • To compare the time to conversion to clinically probable AD in aMCI subjects with normal and abnormal patterns of (18F) flutemetamol uptake based on the visual assessment of a PET scan. [ Time Frame: Time zero equals the date of PET imaging. All subjects will subsequently attend follow-up visits every 6 months for approximately 2 years after the Flutemetamol (18F) Injection administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the time to conversion to clinically probable AD in aMCI subjects below and above a threshold of brain levels of (18F) flutemetamol uptake based on semi-quantitative assessment of a Flutemetamol (18F) Injection PET scan. [ Time Frame: Time zero equals the date of PET imaging. All subjects will subsequently attend follow-up visits every 6 months for approximately 2 years after the Flutemetamol (18F) Injection administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: December 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: 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.
Other Names:
  • Flutemetamol
  • 18F

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028053

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Medpace, Inc.
i3 Statprobe
i3 Research
Investigators
Study Chair: Kim Mansfield GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01028053     History of Changes
Other Study ID Numbers: GE-067-005
Study First Received: December 7, 2009
Last Updated: August 28, 2012
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GE Healthcare:
Mild Cognitive Impairment
Positron Emission Tomography
National Institute of Neurological and Communicative Disorders and Stroke
Alzheimer's Disease and Related Disorders Association
Assess Prognostic Usefulness of Flutemetamol Injection for Identifying Subjects who will Convert to Clinically Probable Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013