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To Compare Positron Emission Tomography (PET) Measurements of Fibrillar Amyloid Burden

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00991419
First received: October 7, 2009
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to compare PET measurements of fibrillar amyloid burden using [18F]AZD4694.


Condition Intervention Phase
Alzheimer's Disease
 Drug: [18F]AZD4694
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase II, Open Label, Non-Randomized Study of [18F]AZD4694 to Compare PET Measurements of Fibrillar Amyloid Burden Obtained Using Difference Scanning Parameters, Reference Region Procedures and to Assess Test-retest Reliability in Patients With AD & HV

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PET Measurements [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: February 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
[18F]4694
 Drug: [18F]AZD4694
[18F]AZD4694 PET Ligand administered at Visit 1, 30 days following screening and at visit 4 for some of the participants.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, of any race or/ethnicity
  • ECG, vital signs, and clinical laboratory values are within normal limits at enrollment or deemed not clinically significant by the physician

Exclusion Criteria:

  • Significant recent (within 6 months) history of neurological (including stroke) or psychiatric disorder or substance abuse
  • Participated in a PET study within the last 12 months
  • Pregnancy or lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991419

Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Eric M Reiman, MD Banner Alzheimer's Institute
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00991419     History of Changes
Other Study ID Numbers: D2750N00006
Study First Received: October 7, 2009
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
PET
Alzheimer's disease
diagnostic

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013