Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β Amyloid

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00692705
First received: June 5, 2008
Last updated: January 22, 2009
Last verified: January 2009

June 5, 2008
January 22, 2009
January 2008
December 2008   (final data collection date for primary outcome measure)
Positron emission tomography using the radioligand (11C)AZD2995 or (11C)AZD2184 [ Time Frame: Radioligand (11C)AZD2995.1-2 PET examinations for AD patients and 1 PET examination for healthy volunteers. - Radioligand (11C) AZD2184.One PET for AD patients respective healthy volunteers. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00692705 on ClinicalTrials.gov Archive Site
To assess safety and tolerability of [11C]AZD2995, [11C]AZD2184 and the study procedures, by assessment of adverse events, vital signs and laboratory variables. [ Time Frame: 3-4 visits with tests for the AD patients. 3 visits with tests for the healthy volunteers. All tests are not done at every visit. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β Amyloid
Open Label Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β 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 [11C]AZD2995, compared to [11C]AZD2184, is a more suitable PET ligand for in vivo imaging of β 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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Alzheimer´s Disease
  • Drug: Radioligand (11C)AZD2995
    Single dose of i.v solution. 1-2 times for AD patients. Once for healthy volunteers.
  • Drug: Radioligand (11C)AZD2184
    Single dose of i.v solution. Once for AD patients respective healthy volunteers.
  • 1
    Alzheimer's Disease (AD) patients
    Interventions:
    • Drug: Radioligand (11C)AZD2995
    • Drug: Radioligand (11C)AZD2184
  • 2
    Healthy volunteers
    Interventions:
    • Drug: Radioligand (11C)AZD2995
    • 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
13
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Alzheimer´s Disease patients - 50-85 years- mild to moderate AD, clinical progression of AD over 12 months.
  • Healthy male volunteers: - Age 20-50 years, Body Mass Index: 18-30 kg/m2.
  • Clinically normal physical findings including normal blood pressure and pulse rate.

Exclusion Criteria:

  • Alzheimer´s Disease patients:
  • significant cerebrovascular disease or depression, central nervous system infarct or infection or lesions
  • clinically significant illness within 2 weeks before the study start.
  • administration of any investigational product with effect on brain beta amyloid levels within 3 months prior to study and/or participation in a PET investigation other than study D0180C00011 as part of a scientific study during the past 12 months,.
  • Healthy volunteers; - clinically significant illness within 2 weeks before the study start, history of psychiatric or somatic disease/condition that may interfere.- first degree relative with dementia. Obvious deterioration of memory functions.
Both
20 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00692705
D0180C00018, Eudract No. 2007-004842-33
No
Märta Segerdahl, Medical Science Director, AstraZeneca, Research and Development, 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, Sweden
Study Director: Emma Gyllenpalm AstraZeneca R&D, Södertälje, Sweden
AstraZeneca
January 2009

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