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An Open Positron Emission Tomography Study to Assess the Effects of Varying Mass of AZD4694 on Radioligand Binding Parameters in Healthy Volunteers and Patients With Alzheimer's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01325402
First Posted: March 29, 2011
Last Update Posted: December 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
In this study different mass of the radioligand AZD4694 will be given to patients with Alzheimer's Disease and healthy volunteers to evaluate wich Mass of AZD4694 that gives the best opportunities for following disease progress and treatment effects.

Condition Intervention Phase
Maximum Diagnostic Mass of [18Fluor]AZD4694 Other: [18Fluor]AZD4694 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Open-Label Positron Emission Tomography Study With Selective Beta Amyloid Radioligand (18Fluor)AZD4694 to Assess the Effects of Varying Mass of AZD4694 on Radioligand Binding Parameters in Healthy Volunteers and Patients With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The Maximum Diagnostic Mass by assessing the visual read out of amyloid status according to and quantification of an [18F]AZD4694 PET image in a high mass experiment compared to the image in a low mass experiment in the same subject. [ Time Frame: Visit 3 ]
    Measuring the maximum chemical mass not causing any significant alteration of the amyloid status (unit = micrograms)

  • The Maximum Diagnostic Mass by assessing the visual read out of amyloid status according to and quantification of an [18F]AZD4694 PET image in a high mass experiment compared to the image in a low mass experiment in the same subject. [ Time Frame: Visit 4 ]
    Measuring the maximum chemical mass not causing any significant alteration of the amyloid status (unit = micrograms)


Secondary Outcome Measures:
  • Number of Adverse Events as a measure of Safety and tolerability of [18F]AZD4694 [ Time Frame: Range of Visits 3-5 ]
  • Correlation between early uptake of [18F]AZD4694 images and cerebral blood flow images as measured by Arterial Spin Labeling Magnetic resonance imaging [ Time Frame: Range of Screening Visit to Visit 4 ]
  • Correlation between estimates of β-amyloid load in brain obtained using [18F]AZD4694 Position Emission Tomography imaging and concentrations of β-amyloid in Cerebrospinal fluid [ Time Frame: Range of Screening Visit to Visit 4 ]

Enrollment: 16
Study Start Date: August 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 Cohort 1
Patients with mild to moderate Alzheimer's Disease
Other: [18Fluor]AZD4694
Low mass dose below 5ug. High mass dose around 40 and 50 ug.
Experimental: Part 1 Cohort 2
Patients with mild to moderate Alzheimer's Disease. To run if Maximum Detective Mass is detected in cohort 1.
Other: [18Fluor]AZD4694
Low mass dose below 5ug. High mass dose around 20 ug.
Experimental: Part 2
Healthy Volunteers
Other: [18Fluor]AZD4694
Low mass dose below 5ug. High mass dose will be the Maximum Detective Mass established in the previous panels.

Detailed Description:
Open-Label Positron Emission Tomography Study with Selective Beta Amyloid Radioligand (18Fluor)AZD4694 to Assess the Effects of Varying Mass of AZD4694 on Radioligand Binding Parameters in Healthy Volunteers and Patients with Alzheimer's Disease
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index between 18 and 30 kg/m2 and weigh at least 50kg and no more than 100 kg.
  • Mini Mental State Examination score >28 (healthy volunteers only)
  • Mini Mental State Examination score 16-28 (Alzheimer's Disease patients only)
  • Hachinski Ischemic Score =4 (Alzheimer's Disease patients only)
  • Clinical diagnosis of probable Alzheimer's Disease according to National Institute of Neurology and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria (Alzheimer's Disease patients only)

Exclusion Criteria:

  • Significant Neurological disease or dementia, as defined clinically or by imaging, other than Alzheimer's Disease that may affect cognition or ability to complete the study (Alzheimer's Disease patients only).
  • Possible, probable or definite vascular dementia in accordance with the National Institute of neurology and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders association criteria (Alzheimer's Disease patients only).
  • Current major depressive disorder or other major psychiatric disorders according to Diagnostic and Statistical Manual of Mental Disorders, edition 4, American Psychiatric Association 1994 criteria (Alzheimer's disease patients only).
  • Depression: Cornell Depression Rating >9 (Alzheimer's disease patients only).
  • Abnormal vital signs defined as any of the following: Systolic blood pressure >180 mmHg, Diastolic blood pressure >90 mmHg, heart rate <40 or>85 beats per minute (Alzheimer's disease patients only).
  • Myocardial infarction or acute coronary syndrome within the last year (Alzheimer's disease patients only).
  • Had Positron Emission Tomography measurements for scientific purposes within the last 12 months.
  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study (healthy volunteers only).
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs (healthy volunteers only).
  • History of previous (within the last 5 years) or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in to Diagnostic and Statistical Manual of Mental Disorders, edition 4, American Psychiatric Association 1994, as assessed by the Mini international neuropsychiatric interview (healthy volunteers only).
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of Investigational Product (healthy volunteers only).
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator (healthy volunteers only).
  • Healthy volunteers<65 years: abnormal vital signs defined as any of the following: Systolic blood pressure >140 mmHg, Diastolic blood pressure >90 mmHg, heart rate <40 or>85 beats per minute.
  • Healthy volunteers≥65 years: abnormal vital signs defined as any of the following: Systolic blood pressure >160 mmHg, Diastolic blood pressure >90 mmHg, heart rate <40 or >85 beats per minute.
  • Central Nervous system infarct, infection of focal lesions of clinical significance on MRI scans as judged by the investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325402


Locations
Sweden
Research Site
Stockholm, Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bjorn Paulsson AstraZeneca
Principal Investigator: Niels Andreasen, MD Geriatric clinic Karolinska University Hospital Huddinge
Principal Investigator: Elisabeth Eden, MD Quintiles Aktiebolag
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01325402     History of Changes
Other Study ID Numbers: D2750C00002
EudraCT # 2011-000095-34
First Submitted: March 21, 2011
First Posted: March 29, 2011
Last Update Posted: December 10, 2012
Last Verified: December 2012

Keywords provided by AstraZeneca:
Radioligand
Alzheimers disease
Maximum Diagnostic Mass
Beta amyloid

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders