Clinical trial NCT01028053: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild Cognitive Impairment
Alzheimer's Disease
Keywords: 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
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
name: i3 Statprobe
name: i3 Research
name: Quintiles, Inc.
First posted: 2009-12-09
Enrollment: 365
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation.
timeFrame: Up to 36 months post flutemetamol administration
Secondary outcomes:
measure: The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period.
timeFrame: Up to 36 months post flutemetamol administration.
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Paul Sherwin, M.D.
role: STUDY_CHAIR
References:
citation: Pichet Binette A, Palmqvist S, Bali D, Farrar G, Buckley CJ, Wolk DA, Zetterberg H, Blennow K, Janelidze S, Hansson O. Combining plasma phospho-tau and accessible measures to evaluate progression to Alzheimer's dementia in mild cognitive impairment patients. Alzheimers Res Ther. 2022 Mar 29;14(1):46. doi: 10.1186/s13195-022-00990-0.