Investigating the Clinical Consequences of Flutemetamol-PET-scanning

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 Overview

• Status: Terminated
• Conditions: Dementia; Mild Cognitive Impairment; Alzheimer's Disease
• Intervention / Treatment: Drug: Flutemetamol (Vizamyl)

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Schlieren, Zurich, Switzerland, 8952
      • University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Three months after initiation of standard treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	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.	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.	Three months after initiation of standard treatment

Other Outcome Measures

Outcome Measure	Time Frame
Comparisons of change from pre-treatment assessment of ADAS-Cog-11 after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status	Six Months after initiation of standard treatment
Comparisons of change from pre-treatment assessment of ADCS-ADL after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status	Six Months after initiation of standard treatment
Comparisons of change from pre-treatment assessment of MMSE after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status	Six Months after initiation of standard treatment
Comparisons of change from pre-treatment assessment of ADCS-CGIC after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status	Six Months after initiation of standard treatment
Change from pre-treatment assessment on the decision regret scale after three months	Three Months after initiation of standard treatment
Change from pre-treatment assessment on the decision regret scale after six months	Six Months after initiation of standard treatment

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: ETH Zurich
• Investigators: Principal Investigator: Christoph Hock, MD, Prof., University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: January 28, 2015
• First Posted (Estimate): February 3, 2015

Study Record Updates

• Last Update Posted (Actual): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: PET; Alzheimer; Mild cognitive impairment; Amyloid; Frontotemporal
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Flutemetamol
• Other Study ID Numbers: Flutemetamol 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided