Clinical trial NCT00838877: Positron Emission Tomography (PET) Study With [18F]AZD4694 and [11C]AZD2184, Candidate PET Ligands for Aβ Amyloid
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
PET
Phase 1
Positron Emission Tomography
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-09
Enrollment: 26
Sex: ALL
Minimum age (years): 50
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 \[18F\]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.


Eligibility criteria: 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.

Primary outcomes:
measure: Positron emission tomography using the radioligand [18F]AZD4694 and/or [11C]AZD2184
timeFrame: 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 outcomes:
measure: To assess safety and tolerability of [18F]AZD4694 and the study procedures, by assessment of adverse events, vital signs, and laboratory variables.
timeFrame: 3-4 visits with tests for AD patients respective healthy volunteers. All tests are not done at every visit.
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Research Site
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
name: Ingemar Bylesjö
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D, Södertälje, Sweden
name: Per Julin
role: STUDY_CHAIR
References: