PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

NCT01053312 | Completed Phase 3 Results DMC

• 1 other identifier: GE 067-008
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Normal Pressure Hydrocephalus

Keywords

Amyloid; NPH Normal pressure hydrocephalus; PET Positron Emission Tomography; SUVR Standard uptake value ratios

Outcome Measures

Primary Outcomes (2)

• Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.

  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.

  Post-contrast administration

• Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.

  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.

  Post-contrast administration

Secondary Outcomes (1)

• Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects

  Post-contrast Administration

Study Arms (1)

1 flutemetamol

EXPERIMENTAL

Drug: [18F] Flutemetamol

Interventions

[18F] Flutemetamol DRUG

All subjects will receive an intravenous (IV) dose of \[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels (MBq).

Also known as: Flutemetamol, AH110690

1 flutemetamol

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• i3 Statprobe: collaborator

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure; Alzheimer Disease

Interventions

flutemetamol

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Paul Sherwin, MD
• Organization: GE Healthcare

paulsherwin@ge.com

1-609-514-6820

Study Officials

• Kim A Mansfield, MS

  GE Healthcare

  STUDY DIRECTOR

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: January 19, 2010
• First Posted: January 21, 2010
• Study Start: December 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 11, 2012
• Results First Posted: June 5, 2012

Record last verified: 2012-06

Locations

US (1)