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

February 6, 2009
October 21, 2009
January 2009
Not Provided
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 ]
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. - Radioligand [11C]AZD2184: 1 PET for AD patients respective healthy volunteers. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00838877 on ClinicalTrials.gov Archive Site
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 ]
To assess safety and tolerability of [18F]AZD4694 and the study procedures, by assessment of adverse events, vital signs, and laboratory variables. [ Time Frame: 4 visits with tests for AD patients respective healthy volunteers. All tests are not done at every visit. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Positron Emission Tomography (PET) Study With [18F]AZD4694 and [11C]AZD2184, Candidate PET Ligands for Aβ Amyloid
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Alzheimer's Disease
  • 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
Experimental: 1
Interventions:
  • Drug: radioligand [18F]AZD4694
  • Drug: radioligand [11C]AZD2184
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
October 2009
Not Provided

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.
Both
50 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00838877
D2750C00001, 2008-006747-39
No
Björn Paulsson, MD, Medical Science Director, AD & Cognition, AstraZeneca R&D Södertälje, Sweden
AstraZeneca
Not Provided
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
AstraZeneca
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP