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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer´s Disease

Intervention / Treatment
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* Drug: Radioligand (11C)AZD2995
* Drug: Radioligand (11C)AZD2184


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Alzheimer's Disease (AD) patients | Drug: Radioligand (11C)AZD2995<br>* Single dose of i.v solution. 1-2 times for AD patients. Once for healthy volunteers.<br>Drug: Radioligand (11C)AZD2184<br>* Single dose of i.v solution. Once for AD patients respective healthy volunteers.<br>|
| Other: 2<br>Healthy volunteers | Drug: Radioligand (11C)AZD2995<br>* Single dose of i.v solution. 1-2 times for AD patients. Once for healthy volunteers.<br>Drug: Radioligand (11C)AZD2184<br>* Single dose of i.v solution. Once for AD patients respective healthy volunteers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer´s Disease, amyloid deposits, Positron Emission Tomography, phase I