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

Alzheimer´s Disease Clinical Trial

— PET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692705
• Other study ID #: D0180C00018
• Secondary ID: Eudract No. 2007
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2008
• Last updated: January 22, 2009
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer´s Disease

Intervention

Drug:
• Radioligand (11C)AZD2995
Single dose of i.v solution. 1-2 times for AD patients. Once for healthy volunteers.
• Radioligand (11C)AZD2184
Single dose of i.v solution. Once for AD patients respective healthy volunteers.

Locations

Country	Name	City	State
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positron emission tomography using the radioligand (11C)AZD2995 or (11C)AZD2184		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.	No
Secondary	To assess safety and tolerability of [11C]AZD2995, [11C]AZD2184 and the study procedures, by assessment of adverse events, vital signs and laboratory variables.		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.	No