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 | Completed Phase 3 Results DMC

• 1 other identifier: GE-067-005
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation.

  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).

  Up to 36 months post flutemetamol administration

Secondary Outcomes (1)

• 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.

Study Arms (1)

Flutemetamol (18F) Injection

EXPERIMENTAL

Flutemetamol (18F) Injection

Drug: Flutemetamol (18F) Injection

Interventions

Flutemetamol (18F) Injection 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.

Also known as: Flutemetamol, 18F

Flutemetamol (18F) Injection

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• Medpace, Inc.: collaborator
• i3 Statprobe: collaborator
• i3 Research: collaborator
• Quintiles, Inc.: collaborator

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Communication Disorders; Stroke

Interventions

flutemetamol

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Paul Sherwin M.D.
• Organization: GE Healthcare

Paul.Sherwin@ge.com

16095146820

Study Officials

• Paul Sherwin, M.D.

  GE Healthcare

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 11, 2014
• Results First Posted: September 11, 2014

Record last verified: 2014-09

Locations

US (1)