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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00692705

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 I

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Parallel Assignment
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

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
Estimated Study Completion Date:	January 2009
Estimated 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

Contacts

Contact: Eva Taavo

+46 8 553 289 77

eva.taavo@astrazeneca.com

Locations

Sweden
Research Site	Recruiting
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

Responsible Party:	AstraZeneca, Research and Development, Sweden ( Märta Segerdahl, Medical Science Director )
Study ID Numbers:	D0180C00018, Eudract No. 2007-004842-33
Study First Received:	June 5, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00692705
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Alzheimer´s Disease
amyloid deposits
Positron Emission Tomography
phase I

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Healthy

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009