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
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 April 17, 2014