Alzheimer's DiseasePhase 1PETNCT00838877
Positron Emission Tomography (PET) Study With [18F]AZD4694 and [11C]AZD2184, Candidate PET Ligands for Aβ Amyloid
A Phase 1 study testing radioligand [18F]AZD4694 and radioligand [11C]AZD2184 in people with Alzheimer's Disease, run by AstraZeneca at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- radioligand [18F]AZD4694 and radioligand [11C]AZD2184
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2009to Oct 2009
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
- Conditions
- Alzheimer's Disease
- Being tested
- radioligand [18F]AZD4694, radioligand [11C]AZD2184
- Keywords
- Alzheimer's Disease, PET, Phase 1, Positron Emission Tomography
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radioligand [18F]AZD4694Drug
single dose of iv. admin. 1-2 times per subject
radioligand [11C]AZD2184Drug
single dose of iv admin. 1 time per subject
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: radioligand [18F]AZD4694; Drug: radioligand [11C]AZD2184 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positron emission tomography using the radioligand [18F]AZD4694 and/or [11C]AZD2184
Measured: 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 (1)
To assess safety and tolerability of [18F]AZD4694 and the study procedures, by assessment of adverse events, vital signs, and laboratory variables.
Measured: 3-4 visits with tests for AD patients respective healthy volunteers. All tests are not done at every visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startJan 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Maria E Jönhagen, Principal investigator, Geriatric Clinic, Karolinska University Hospital, Huddinge, SwedenIngemar Bylesjö, Principal investigator, AstraZeneca Clinical Pharmacology Unit, StockholmPer Julin, Study chair, AstraZeneca R&D, Södertälje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838877
- Sponsor's protocol ID
- D2750C00001
- Other IDs
- 2008-006747-39, 2008
- Acronym
- PET
- Status last verified
- Oct 2009
- First submitted
- 6 Feb 2009
- Last updated
- 23 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00838877
- Acronym / sponsor ID
- PET / D2750C00001
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, PET, Phase 1, Positron Emission Tomography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Study completion
- Oct 2009 (actual)
- First posted
- 9 Feb 2009 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: radioligand [18F]AZD4694, Drug: radioligand [11C]AZD2184 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| radioligand [18F]AZD4694single dose of iv. admin. 1-2 times per subject | Drug | 1 |
| radioligand [11C]AZD2184single dose of iv admin. 1 time per subject | Drug | 1 |
Primary outcome
Positron emission tomography using the radioligand [18F]AZD4694 and/or [11C]AZD2184
Time frame: 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.
1 secondary outcome
To assess safety and tolerability of [18F]AZD4694 and the study procedures, by assessment of adverse events, vital signs, and laboratory variables.
Time frame: 3-4 visits with tests for AD patients respective healthy volunteers. All tests are not done at every visit.
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 23 Oct 2009.
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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.
Maria E Jönhagen principal investigator
Geriatric Clinic, Karolinska University Hospital, Huddinge, Sweden
Ingemar Bylesjö principal investigator
AstraZeneca Clinical Pharmacology Unit, Stockholm
Per Julin study chair
AstraZeneca R&D, Södertälje, Sweden
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 radioligand [18F]AZD4694 and radioligand [11C]AZD2184 in people with Alzheimer's Disease, 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 4 inclusion and 4 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 23 Oct 2009. 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?
Positron emission tomography using the radioligand [18F]AZD4694 and/or [11C]AZD2184 (time frame: 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.). 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 23 Oct 2009.