Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

NCT01092546 | Terminated Phase 3 Results DMC

• 1 other identifier: GE-067-009
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the level of association between the quantitative estimates of brain uptake of \[18F\]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement for NPH.

Conditions

Normal Pressure Hydrocephalus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region.

  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 obtained during shunt placement in patients who have Normal Pressure Hydrocephalus (NPH). The quantitative estimates of brain uptake of \[18F\]flutemetamol (SUVR) will be made from the analysis of PET images.

  Post flutemetamol Injection

Secondary Outcomes (1)

• Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region.

  Post flutemetamol administration

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: [18F]Flutemetamol

Interventions

[18F]Flutemetamol DRUG

All subjects will receive an IV 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, AH110690

Arm 1

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 at least 50 years of age.
• The subjects' general health is adequate to comply with study procedures.
• The subject has been scheduled for a shunt placement procedure for the treatment of NPH.

You may not qualify if:

• The subject has a contraindication for MRI or PET.
• The subject is pregnant or lactating.
• The subject has a known or suspected hypersensitivity/allergy to \[18F\]flutemetamol or to any of the excipients.
• 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, M.D.
• Organization: GE Healthcare

Paul.Sherwin@ge.com

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: March 23, 2010
• First Posted: March 25, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 13, 2013
• Results First Posted: November 19, 2013

Record last verified: 2013-11

Locations

US (1)