Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects

NCT01265394 | Completed Phase 3 Results

• 1 other identifier: GE-067-015
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects.

Conditions

Healthy

Keywords

Amyloid; Magnetic resonance imaging; Positron Emission Tomography; Standard uptake value ratios; Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid

  The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging. The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading).

  PET scans performed on patients 90 minutes post Flutemetmol Administration

Secondary Outcomes (1)

• Measurement of Amyloid Content in Different Parts of the Brain

  PET scans performed on patients 90 minutes post Flutemetmol Administration

Study Arms (1)

(18F) Flutemetamol

EXPERIMENTAL

Drug: [18F] Flutemetamol

Interventions

[18F] Flutemetamol DRUG

Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.

Also known as: AH110690

(18F) Flutemetamol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject age is 18 to 40 years.
• The subject has no evidence of thinking or memory problems by medical history.
• The subject has a normal MRI scan.
• The subject's general health is adequate to comply with study procedures.
• The subject is willing and able to participate in all study procedures.

You may not qualify if:

• The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT).
• The subject has a contraindication for (cannot undergo) MRI.
• The subject has a history of head injury with loss of consciousness.
• The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology.
• The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative.

Sponsors & Collaborators

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

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

flutemetamol

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Paul Sherwin
• Organization: GE Healthcare

paulsherwin@ge.com

1-609-514-6820

Study Officials

• Paul Sherwin, MD, PhD

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: December 23, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 2, 2013
• Results First Posted: June 21, 2013

Record last verified: 2013-06

Locations

US (1)