This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: February 6, 2009
Last updated: October 21, 2009
Last verified: October 2009
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: 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

Resource links provided by NLM:

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. ]

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. ]

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


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
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.
  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 identifier: 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
  More Information

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
Study First Received: February 6, 2009
Last Updated: October 21, 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 processed this record on September 21, 2017