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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

Primary Purpose

Mild Cognitive Impairment, Alzheimer's Disease

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Flutemetamol (18F) Injection

About this trial

This is an interventional diagnostic trial for Mild Cognitive Impairment focused on measuring 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

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

GE Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Flutemetamol (18F) Injection

Arm Description

Flutemetamol (18F) Injection

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period.

Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD.

Full Information

NCT ID

NCT01028053

First Posted

December 7, 2009

Last Updated

September 3, 2014

Sponsor

GE Healthcare

Collaborators

Medpace, Inc., i3 Statprobe, i3 Research, Quintiles, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01028053

Brief Title

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

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GE Healthcare

Collaborators

Medpace, Inc., i3 Statprobe, i3 Research, Quintiles, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

365 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flutemetamol (18F) Injection

Arm Type

Experimental

Arm Description

Flutemetamol (18F) Injection

Intervention Type

Drug

Intervention Name(s)

Flutemetamol (18F) Injection

Other Intervention Name(s)

Flutemetamol, 18F

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to 36 months post flutemetamol administration

Secondary Outcome Measure Information:

Title

The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period.

Description

Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD.

Time Frame

Up to 36 months post flutemetamol administration.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Sherwin, M.D.

Organizational Affiliation

GE Healthcare

Official's Role

Study Chair

Facility Information:

Facility Name

GE Healthcare

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35351181

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.

Results Reference

derived

Learn more about this trial

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

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