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Investigating the Clinical Consequences of Flutemetamol-PET-scanning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353949
Recruitment Status : Terminated (Insufficient Recruitment)
First Posted : February 3, 2015
Last Update Posted : January 21, 2020
Sponsor:
Collaborator:
ETH Zurich
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer's Disease Dementia Drug: Flutemetamol (Vizamyl) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigating the Clinical Consequences of Flutemetamol-PET-scanning
Study Start Date : May 2015
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : December 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Experimental: Flutmetamol Group
PET-MR-Scan with 80-140 MBq Flutemetamol before observational period for diagnostic purpose
Drug: Flutemetamol (Vizamyl)
PET-MR Scan using the radiotracer Flutemetamol (Vizamyl) for diagnostic purpose




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 Outcome Measures:
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Change from pre-treatment assessment on the decision regret scale after three months [ Time Frame: Three Months after initiation of standard treatment ]
  6. Change from pre-treatment assessment on the decision regret scale after six months [ Time Frame: Six Months after initiation of standard treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353949


Locations
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Switzerland
University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy
Schlieren, Zurich, Switzerland, 8952
Sponsors and Collaborators
University of Zurich
ETH Zurich
Investigators
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Principal Investigator: Christoph Hock, MD, Prof. University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02353949    
Other Study ID Numbers: Flutemetamol 2
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Zurich:
Mild cognitive impairment
Alzheimer
PET
Amyloid
Frontotemporal
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Flutemetamol
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action