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

General Electric (GE) logo

General Electric (GE)

Status and phase

Completed
Phase 3

Conditions

Healthy

Treatments

Drug: [18F] Flutemetamol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01265394
GE-067-015

Details and patient eligibility

About

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.

Enrollment

218 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

218 participants in 1 patient group

(18F) Flutemetamol
Experimental group
Treatment:
Drug: [18F] Flutemetamol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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