Mild Cognitive ImpairmentPhase 3NCT02353949
Investigating the Clinical Consequences of Flutemetamol-PET-scanning
A Phase 3 study testing Flutemetamol (Vizamyl) in people with Mild Cognitive Impairment and Alzheimer's Disease, run by University of Zurich at 1 site in Switzerland.
Trial summary
The study examines subjects where there might be an indication for Amyloid-PET according to the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and disease course will be studied over 6 months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease, Dementia
- What is being tested?
- Flutemetamol (Vizamyl)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2015to 10 Dec 2019
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dementia expert considers an Amyloid-scan appropriate according to Amyloid-imaging task force criteria (AIT) after conference with an Amyloid-PET expert
- Preambles of the AIT-Criteria are fulfilled
- A cognitive complaint with objectively confirmed impairment
- AD as a possible diagnosis, but when the diagnosis is uncertain after a comprehensive evaluation by a dementia expert
- When knowledge of the presence or absence of Abeta pathology is expected to increase diagnostic certainty and alter Management
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- Patients with persistent or progressive unexplained MCI
- Patients satisfying core clinical criteria for possible AD because of unclear clinical presentation, either an atypical clinical course or an etiologically mixed presentation
- Patients with progressive dementia and atypically early age of onset (65 years or less in age)
- other situations where preambles of AIT-Criteria are fulfilled
- Diagnosis was established in a memory clinic or by an experienced physician in dementia diagnostics
- The diagnostic procedures comprise in minimum MRI, neuropsychology, routine blood test for exclusion of symptomatic causes
- MMSE >15
- Competency to consent
- Trial partner willing to support study physician
- Written informed consent by both patient and trial partner
- Understanding of German language
- Treating physician willing to collaborate with the study team
Who cannot join
- Cognitive impairment which can be attributed to another underlying medical condition that renders a possibility of Alzheimer's disease very unlikely (thus violating preamble B)
- Clinically significant Depression (decided upon clinical assessment)
- MRI exclusion criteria
- PET exclusion criteria
- Allergy to Flutemetamol or any of the excipients of the solution for injections
- History of severe allergic reactions to drugs or allergens
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy
Schlieren, Canton of Zurich, 8952
About this study
The study examines subjects where there might be an indication for Amyloid-PET according to the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and disease course will be studied over 6 months.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease, Dementia
- Being tested
- Flutemetamol (Vizamyl)
- Keywords
- Mild cognitive impairment, Alzheimer, PET, Amyloid, Frontotemporal
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flutemetamol (Vizamyl)Drug
PET-MR Scan using the radiotracer Flutemetamol (Vizamyl) for diagnostic purpose
| Study group | Role | What they receive |
|---|---|---|
| Flutmetamol Group | Experimental | PET-MR-Scan with 80-140 MBq Flutemetamol before observational period for diagnostic purpose Receives: Drug: Flutemetamol (Vizamyl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ADAS-cog 11 score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.
Measured: Three months after initiation of standard treatment
Secondary outcomes (3)
Change of ADCS-ADL score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.
Measured: Three months after initiation of standard treatment
Change of ADCS-CGIC score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.
Measured: Three months after initiation of standard treatment
Change of MMSE score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.
Measured: Three months after initiation of standard treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startMay 2015
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Why it stopped: Insufficient Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich
- Responsible party
- Sponsor
- Investigators
- Christoph Hock, MD, Prof., Principal investigator, University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353949
- Sponsor's protocol ID
- Flutemetamol 2
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2015
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Clinical Consequences of Flutemetamol-PET-scanning
- ClinicalTrials.gov ID
- NCT02353949
- Acronym / sponsor ID
- Flutemetamol 2
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease, Dementia
- Keywords
- Mild cognitive impairment, Alzheimer, PET, Amyloid, Frontotemporal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- ETH Zurich
- Study start
- May 2015
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 3 Feb 2015 (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 examines subjects where there might be an indication for Amyloid-PET according to the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and disease course will be studied over 6 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flutmetamol Group | Experimental | Drug: Flutemetamol (Vizamyl)PET-MR-Scan with 80-140 MBq Flutemetamol before observational period for diagnostic purpose |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Dementia expert considers an Amyloid-scan appropriate according to Amyloid-imaging task force criteria (AIT) after conference with an Amyloid-PET expert
- Preambles of the AIT-Criteria are fulfilled
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- Diagnosis was established in a memory clinic or by an experienced physician in dementia diagnostics
- The diagnostic procedures comprise in minimum MRI, neuropsychology, routine blood test for exclusion of symptomatic causes
Key exclusion criteria (7 listed)
- Cognitive impairment which can be attributed to another underlying medical condition that renders a possibility of Alzheimer's disease very unlikely (thus violating preamble B)
- Clinically significant Depression (decided upon clinical assessment)
- MRI exclusion criteria
- PET exclusion criteria
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 |
|---|---|---|
| Flutemetamol (Vizamyl)PET-MR Scan using the radiotracer Flutemetamol (Vizamyl) for diagnostic purpose | Drug | Flutmetamol Group |
Primary outcome
Change of ADAS-cog 11 score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.
Time frame: Three months after initiation of standard treatment
3 secondary outcomes
Change of ADCS-ADL score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.
Time frame: Three months after initiation of standard treatment
Change of ADCS-CGIC score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.
Time frame: Three months after initiation of standard treatment
Change of MMSE score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.
Time frame: Three months after initiation of standard treatment
Results and safety
The study was stopped early (reason given: Insufficient Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Christoph Hock, MD, Prof. principal investigator
University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flutemetamol (Vizamyl) in people with Mild Cognitive Impairment and Alzheimer's Disease, run by University of Zurich at 1 site in Switzerland.
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 18 inclusion and 7 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: stopped early, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Insufficient Recruitment). Results are not available in the source record.
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?
Change of ADAS-cog 11 score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment. (time frame: Three months after initiation of standard treatment). 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 21 Jan 2020.