Maximum Diagnostic Mass of [18Fluor]AZD4694Phase 1NCT01325402
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
A Phase 1 study testing [18Fluor]AZD4694 in people with Maximum Diagnostic Mass of [18Fluor]AZD4694, run by AstraZeneca at 2 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Maximum Diagnostic Mass of [18Fluor]AZD4694
- What is being tested?
- [18Fluor]AZD4694
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesSweden
- Study dates
- Aug 2011to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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
- Being tested
- [18Fluor]AZD4694
- Keywords
- Radioligand, Alzheimers disease, Maximum Diagnostic Mass, Beta amyloid
- Medical subject headings
- Alzheimer Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18Fluor]AZD4694Other
Low mass dose below 5ug. High mass dose around 40 and 50 ug.
[18Fluor]AZD4694Other
Low mass dose below 5ug. High mass dose around 20 ug.
[18Fluor]AZD4694Other
Low mass dose below 5ug. High mass dose will be the Maximum Detective Mass established in the previous panels.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1 | Experimental | Patients with mild to moderate Alzheimer's Disease Receives: Other: [18Fluor]AZD4694 |
| Part 1 Cohort 2 | Experimental | Patients with mild to moderate Alzheimer's Disease. To run if Maximum Detective Mass is detected in cohort 1. Receives: Other: [18Fluor]AZD4694 |
| Part 2 | Experimental | Healthy Volunteers Receives: Other: [18Fluor]AZD4694 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measuring the maximum chemical mass not causing any significant alteration of the amyloid status (unit = micrograms)
Measured: Visit 3
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.
Measuring the maximum chemical mass not causing any significant alteration of the amyloid status (unit = micrograms)
Measured: Visit 4
Secondary outcomes (3)
Number of Adverse Events as a measure of Safety and tolerability of [18F]AZD4694
Measured: 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
Measured: 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
Measured: Range of Screening Visit to Visit 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maximum Diagnostic Mass of [18Fluor]AZD4694Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bjorn Paulsson, Study director, AstraZenecaNiels Andreasen, MD, Principal investigator, Geriatric clinic Karolinska University Hospital HuddingeElisabeth Eden, MD, Principal investigator, Quintiles Aktiebolag
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325402
- Sponsor's protocol ID
- D2750C00002
- Other IDs
- EudraCT # 2011-000095-34
- Status last verified
- Dec 2012
- First submitted
- 21 Mar 2011
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01325402
- Acronym / sponsor ID
- D2750C00002
- Keywords
- Radioligand, Alzheimers disease, Maximum Diagnostic Mass, Beta amyloid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1 | Experimental | Other: [18Fluor]AZD4694Patients with mild to moderate Alzheimer's Disease |
| Part 1 Cohort 2 | Experimental | Other: [18Fluor]AZD4694Patients with mild to moderate Alzheimer's Disease. To run if Maximum Detective Mass is detected in cohort 1. |
| Part 2 | Experimental | Other: [18Fluor]AZD4694Healthy Volunteers |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18Fluor]AZD4694Low mass dose below 5ug. High mass dose around 40 and 50 ug. | Other | Part 1 Cohort 1 |
| [18Fluor]AZD4694Low mass dose below 5ug. High mass dose around 20 ug. | Other | Part 1 Cohort 2 |
| [18Fluor]AZD4694Low mass dose below 5ug. High mass dose will be the Maximum Detective Mass established in the previous panels. | Other | Part 2 |
Primary outcome
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)
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjorn Paulsson study director
AstraZeneca
Niels Andreasen, MD principal investigator
Geriatric clinic Karolinska University Hospital Huddinge
Elisabeth Eden, MD principal investigator
Quintiles Aktiebolag
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18Fluor]AZD4694 in people with Maximum Diagnostic Mass of [18Fluor]AZD4694, run by AstraZeneca at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2012.