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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
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    1. A cognitive complaint with objectively confirmed impairment
    2. AD as a possible diagnosis, but when the diagnosis is uncertain after a comprehensive evaluation by a dementia expert
    3. When knowledge of the presence or absence of Abeta pathology is expected to increase diagnostic certainty and alter Management
    1. Patients with persistent or progressive unexplained MCI
    2. Patients satisfying core clinical criteria for possible AD because of unclear clinical presentation, either an atypical clinical course or an etiologically mixed presentation
    3. Patients with progressive dementia and atypically early age of onset (65 years or less in age)
    4. 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

    1. Allergy to Flutemetamol or any of the excipients of the solution for injections
    2. History of severe allergic reactions to drugs or allergens
    3. 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

First Posted
January 22, 2015
Last Updated
January 16, 2020
Sponsor
University of Zurich
Collaborators
ETH Zurich
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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

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Investigating the Clinical Consequences of Flutemetamol-PET-scanning

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