PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Phase 3

Completed

• Conditions: Normal Pressure Hydrocephalus
• Interventions: Drug: [18F] Flutemetamol

• Registration Number: NCT01053312
• Lead Sponsor: GE Healthcare

Brief Summary

This study will determine the level of association between the quantitative estimates of brain uptake of \[18F\]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-21
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Results First Submitted: 2012-03-28
• Results First Submitted QC: 2012-05-02
• Status Verified: 2012-06
• Results First Posted: 2012-06-05
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• The subject is 50 years old or older.
• The subject has had a frontal lobe cortical biopsy adequate for the detection and quantitation of amyloid.
• Informed consent has been signed and dated by the subject/and/or subjects' legally acceptable representative, if applicable, in accordance with local regulations.

Exclusion Criteria

• The subject has a contraindication for MRI or PET.
• The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol.
• The subject has participated in any clinical study using an investigational agent within 30 days of dosing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 flutemetamol	[18F] Flutemetamol	-

Primary Outcome Measures

Name	Time	Method
Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.	Post-contrast administration	Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV_voi/SUV_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV_voi) or reference region (SUV_ref). VOI means volume of interest and REF means reference region.
Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.	Post-contrast administration	This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228.

Secondary Outcome Measures

Name	Time	Method
Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects	Post-contrast Administration	Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of \[18F\] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States