Positron Emission Tomography (PET) Study With [18F]AZD4694 and [11C]AZD2184, Candidate PET Ligands for Aβ Amyloid

Alzheimer's Disease Clinical Trial

— PET  

Official title:

Open Label Positron Emission Tomography Study With [18F]AZD4694 and [11C]AZD2184, Candidate Radioligands for AB 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: NCT00838877
• Other study ID #: D2750C00001
• Secondary ID: 2008-006747-39
• Status: Completed
• Phase: Phase 1
• First received: February 6, 2009
• Last updated: October 21, 2009
• Start date: January 2009
• Est. completion date: October 2009

Study information

• Verified date: October 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 [18F]AZD4694, compared to [11C]AZD2184, is a suitable PET ligand for in vivo imaging of Aβ 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. A whole body dosimetry scanning will be performed in 6 healthy volunteers to obtain human data to estimate a safe dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Alzheimer's Disease patients - 50-85 years, mild to moderate AD: MMSE =16 and = 26, clinical progression of AD over 12 months.

• Healthy volunteers: - 50-75 years

• BMI 18 and 30 m2/kg

• Clinically normal physical findings including supine blood pressure and pulse rate.

Exclusion Criteria:

• Alzheimer's Disease patients - Clinically significant illness the 2 weeks prior to the administration of the PET ligand

• Significant cerebrovascular disease or depression, central nervous system infarct or infection or lesions

• Administration of any investigational product within 3 months prior to study and/or PET measurements for scientific purposes within the last 12 months.

• Healthy volunteers - clinically significant illness within 2 weeks before administration of PET ligand, 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 [18F]AZD4694
single dose of iv. admin. 1-2 times per subject
• radioligand [11C]AZD2184
single dose of iv admin. 1 time per subject

Locations

Country	Name	City	State
Sweden	Research Site	Huddinge
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 [18F]AZD4694 and/or [11C]AZD2184		Radioligand [18F]AZD4694: 1-2 PET examinations for AD patients and 1 PET examination for healthy volunteers. Whole body dosimetri for some healthy volunteers. - Radioligand [11C]AZD2184: 1 PET for AD patients respective healthy volunteers.	No
Secondary	To assess safety and tolerability of [18F]AZD4694 and the study procedures, by assessment of adverse events, vital signs, and laboratory variables.		3-4 visits with tests for AD patients respective healthy volunteers. All tests are not done at every visit.	No