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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991419
First Posted: October 8, 2009
Last Update Posted: January 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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: None (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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PET Measurements [ Time Frame: Day 1 and Day 7 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00991419     History of Changes
Other Study ID Numbers: D2750N00006
First Submitted: October 7, 2009
First Posted: October 8, 2009
Last Update Posted: January 30, 2013
Last Verified: January 2013

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
Neurocognitive Disorders
Mental Disorders