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

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. Identifier: NCT00991419
Recruitment Status : Completed
First Posted : October 8, 2009
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: [18F]AZD4694 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : February 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: A
Drug: [18F]AZD4694
[18F]AZD4694 PET Ligand administered at Visit 1, 30 days following screening and at visit 4 for some of the participants.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00991419

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

Responsible Party: AstraZeneca Identifier: NCT00991419     History of Changes
Other Study ID Numbers: D2750N00006
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013

Keywords provided by AstraZeneca:
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders