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

NCT01028053 — Phase 3, Completed, 365 participants, GE Healthcare

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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

RegistryNCT01028053
StatusCompleted
PhasePhase 3
Study typeInterventional; na, single group, masking: none, diagnostic
Enrollment365 (Actual)
SponsorGE Healthcare (Industry); collaborators: Medpace, Inc., i3 Statprobe, i3 Research, Quintiles, Inc.
ConditionsMild Cognitive Impairment, Alzheimer's Disease
InterventionsFlutemetamol (18F) Injection (Drug)
Datesstart 2009-12-01, primary completion 2014-01-01, completion 2014-01-01, first posted 2009-12-09, last updated 2014-09-11
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Mild Cognitive Impairment All trials for Alzheimer's Disease All trials of Flutemetamol (18F) Injection

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Flutemetamol (18F) InjectionExperimentalDrug: Flutemetamol (18F) InjectionFlutemetamol (18F) Injection
  • Flutemetamol (18F) Injection (Drug), also known as Flutemetamol, 18F: 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.

+Outcome measures

Primary outcomes

  • Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation. [Up to 36 months post flutemetamol administration]: Visual Interpretation of the PET scan by independent readers. Note: The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1. As the HR increases above 1, the chances of being probable Alzheimer's Disease (pAD) also increases. Note: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 - 8 = 224 Subjects included).

Secondary outcomes

  • The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. [Up to 36 months post flutemetamol administration.]: Numbers of subjects with normal and abnormal patterns of \[18F\]flutemetamol uptake who converted to pAD.

+Eligibility

Sex: All, ages: 60 Years to any

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.

+Posted results

Participant flow

MilestoneFlutemetamol (18F) Injection
Started365
Completed232
Not completed133

Outcome results

  • Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation. (Primary), Number, Ratio of visual interpretations: Hazard Ratio 3.418
  • The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. (Secondary), Number, Number of subjects: Not Clinically Probable Alzheimer's Disease 111; Clinically Probable Alzheimer's Disease 31

Adverse events

ArmDeathsSerious adverse eventsOther adverse events
Flutemetamol (18F) Injection01/232 (0.4%)0/232 (0.0%)

Serious adverse events by term

TermOrgan systemFlutemetamol (18F) Injection
Anaphylactoid ReactionImmune system disorders1/232

+Locations (1)

FacilityCityCountryStatus
GE HealthcarePrinceton, New JerseyUnited States

+Publications

  • Results publication: 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. PMID 35351181

+Investigators