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
  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:


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
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, see Learn About Clinical Studies.

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 September 30, 2014