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Positron Emission Tomography (PET) Study With [18F]AZD4694 and [11C]AZD2184, Candidate PET Ligands for Aβ Amyloid

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00838877
First received: February 6, 2009
Last updated: October 21, 2009
Last verified: October 2009
History of Changes
  Purpose

The study is carried out in order to investigate if [18F]AZD4694, compared to [11C]AZD2184, is a suitable PET ligand for in vivo imaging of Aβ amyloid depositions in the human brain. In the study the two PET ligands will be examined in both healthy volunteers and patients with Alzheimer's Disease. A whole body dosimetry scanning will be performed in 6 healthy volunteers to obtain human data to estimate a safe dose.


Condition Intervention Phase
Alzheimer's Disease
 Drug: radioligand [18F]AZD4694
Drug: radioligand [11C]AZD2184
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Open Label Positron Emission Tomography Study With [18F]AZD4694 and [11C]AZD2184, Candidate Radioligands for AB Amyloid, to Determine and Compare in Vivo Brain Uptake and Distribution in Healthy Volunteers and Patients With Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Positron emission tomography using the radioligand [18F]AZD4694 and/or [11C]AZD2184 [ Time Frame: Radioligand [18F]AZD4694: 1-2 PET examinations for AD patients and 1 PET examination for healthy volunteers. Whole body dosimetri for some healthy volunteers. - Radioligand [11C]AZD2184: 1 PET for AD patients respective healthy volunteers. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess safety and tolerability of [18F]AZD4694 and the study procedures, by assessment of adverse events, vital signs, and laboratory variables. [ Time Frame: 3-4 visits with tests for AD patients respective healthy volunteers. All tests are not done at every visit. ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: January 2009
Study Completion Date: October 2009
Arms Assigned Interventions
Experimental: 1 Drug: radioligand [18F]AZD4694
single dose of iv. admin. 1-2 times per subject
Drug: radioligand [11C]AZD2184
single dose of iv admin. 1 time per subject

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Alzheimer's Disease patients - 50-85 years, mild to moderate AD: MMSE ≥16 and ≤ 26, clinical progression of AD over 12 months.
  • Healthy volunteers: - 50-75 years
  • BMI 18 and 30 m2/kg
  • Clinically normal physical findings including supine blood pressure and pulse rate.

Exclusion Criteria:

  • Alzheimer's Disease patients - Clinically significant illness the 2 weeks prior to the administration of the PET ligand
  • Significant cerebrovascular disease or depression, central nervous system infarct or infection or lesions
  • Administration of any investigational product within 3 months prior to study and/or PET measurements for scientific purposes within the last 12 months.
  • Healthy volunteers - clinically significant illness within 2 weeks before administration of PET ligand, history of psychiatric or somatic disease/condition that may interfere, first degree relative with dementia. Obvious deterioration of memory functions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838877

Locations
Sweden
Research Site
Huddinge, Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Maria E Jönhagen Geriatric Clinic, Karolinska University Hospital, Huddinge, Sweden
Principal Investigator: Ingemar Bylesjö AstraZeneca Clinical Pharmacology Unit, Stockholm
Study Chair: Per Julin AstraZeneca R&D, Södertälje, Sweden
  More Information

No publications provided

Responsible Party: Björn Paulsson, MD, Medical Science Director, AD & Cognition, AstraZeneca R&D Södertälje, Sweden
ClinicalTrials.gov Identifier: NCT00838877     History of Changes
Other Study ID Numbers: D2750C00001, 2008-006747-39
Study First Received: February 6, 2009
Last Updated: October 21, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Alzheimer's Disease
PET
Phase 1
Positron Emission Tomography

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 22, 2013