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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00838877

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: radioligand [18F]AZD4694 Drug: radioligand [11C]AZD2184	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Study Start Date :

Jan 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: radioligand [18F]AZD4694 single dose of iv. admin. 1-2 times per subject Drug: radioligand [11C]AZD2184 single dose of iv admin. 1 time per subject

Arm

Intervention/Treatment

Experimental: 1

Drug: radioligand [18F]AZD4694

single dose of iv. admin. 1-2 times per subject

Drug: radioligand [11C]AZD2184

single dose of iv admin. 1 time per subject

Outcome Measures

Primary Outcome Measures

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.]

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Huddinge		Sweden
2	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
Study Chair: Per Julin, AstraZeneca R&D, Södertälje, Sweden