Clinical trial NCT00692705: Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β Amyloid
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer´s Disease
Keywords: Alzheimer´s Disease
amyloid deposits
Positron Emission Tomography
phase I
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Positron emission tomography using the radioligand (11C)AZD2995 or (11C)AZD2184
timeFrame: 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 outcomes:
measure: To assess safety and tolerability of [11C]AZD2995, [11C]AZD2184 and the study procedures, by assessment of adverse events, vital signs and laboratory variables.
timeFrame: 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.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: Geriatric Clinic, Karolinska University Hospital, Huddinge, Sweden
name: Maria E Jönhagen
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
name: Ingemar Bylesjö
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D, Södertälje, Sweden
name: Emma Gyllenpalm
role: STUDY_DIRECTOR
References: