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

Phase 1

Completed

• Conditions: Alzheimer´s Disease
• Interventions: Drug: Radioligand (11C)AZD2995; Drug: Radioligand (11C)AZD2184

• Registration Number: NCT00692705
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-22
• Last Update Posted: 2009-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Radioligand (11C)AZD2995	Alzheimer's Disease (AD) patients
1	Radioligand (11C)AZD2184	Alzheimer's Disease (AD) patients
2	Radioligand (11C)AZD2995	Healthy volunteers
2	Radioligand (11C)AZD2184	Healthy volunteers

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden