Investigating the Clinical Consequences of Flutemetamol-PET-scanning
Primary Purpose
Mild Cognitive Impairment, Alzheimer's Disease, Dementia
Status
Terminated
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Flutemetamol (Vizamyl)
Sponsored by
About this trial
This is an interventional diagnostic trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment, Alzheimer, PET, Amyloid, Frontotemporal
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Flutmetamol Group
Arm Description
PET-MR-Scan with 80-140 MBq Flutemetamol before observational period for diagnostic purpose
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02353949
First Posted
January 22, 2015
Last Updated
January 16, 2020
Sponsor
University of Zurich
Collaborators
ETH Zurich
1. Study Identification
Unique Protocol Identification Number
NCT02353949
Brief Title
Investigating the Clinical Consequences of Flutemetamol-PET-scanning
Official Title
Investigating the Clinical Consequences of Flutemetamol-PET-scanning
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Recruitment
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
ETH Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer's Disease, Dementia
Keywords
Mild cognitive impairment, Alzheimer, PET, Amyloid, Frontotemporal
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flutmetamol Group
Arm Type
Experimental
Arm Description
PET-MR-Scan with 80-140 MBq Flutemetamol before observational period for diagnostic purpose
Intervention Type
Drug
Intervention Name(s)
Flutemetamol (Vizamyl)
Intervention Description
PET-MR Scan using the radiotracer Flutemetamol (Vizamyl) for diagnostic purpose
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Other Pre-specified Outcome Measures:
Title
Comparisons of change from pre-treatment assessment of ADAS-Cog-11 after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status
Time Frame
Six Months after initiation of standard treatment
Title
Comparisons of change from pre-treatment assessment of ADCS-ADL after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status
Time Frame
Six Months after initiation of standard treatment
Title
Comparisons of change from pre-treatment assessment of MMSE after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status
Time Frame
Six Months after initiation of standard treatment
Title
Comparisons of change from pre-treatment assessment of ADCS-CGIC after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status
Time Frame
Six Months after initiation of standard treatment
Title
Change from pre-treatment assessment on the decision regret scale after three months
Time Frame
Three Months after initiation of standard treatment
Title
Change from pre-treatment assessment on the decision regret scale after six months
Time Frame
Six Months after initiation of standard treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Hock, MD, Prof.
Organizational Affiliation
University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy
City
Schlieren
State/Province
Zurich
ZIP/Postal Code
8952
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Investigating the Clinical Consequences of Flutemetamol-PET-scanning
We'll reach out to this number within 24 hrs