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
  Purpose

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.


Condition Intervention Phase
Alzheimer´s Disease
Drug: Radioligand (11C)AZD2995
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 (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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 13
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Alzheimer's Disease (AD) patients
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.
2
Healthy volunteers
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.

  Eligibility

Ages Eligible for Study:   20 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, 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.
  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 ClinicalTrials.gov identifier: NCT00692705

Locations
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, Sweden
Study Director: Emma Gyllenpalm AstraZeneca R&D, Södertälje, Sweden
  More Information

No publications provided

Responsible Party: Märta Segerdahl, Medical Science Director, AstraZeneca, Research and Development, Sweden
ClinicalTrials.gov Identifier: NCT00692705     History of Changes
Other Study ID Numbers: D0180C00018, Eudract No. 2007-004842-33
Study First Received: June 5, 2008
Last Updated: January 22, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Alzheimer´s Disease
amyloid deposits
Positron Emission Tomography
phase I

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 September 22, 2014