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

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: NCT00838877
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : October 23, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: radioligand [18F]AZD4694 Drug: radioligand [11C]AZD2184 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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): NCT00838877

Research Site
Huddinge, Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
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

Responsible Party: Björn Paulsson, MD, Medical Science Director, AD & Cognition, AstraZeneca R&D Södertälje, Sweden Identifier: NCT00838877     History of Changes
Other Study ID Numbers: D2750C00001
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: October 23, 2009
Last Verified: October 2009

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

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