Investigating the Clinical Consequences of Flutemetamol-PET-scanning

NCT02353949 | Terminated Phase 3

• 1 other identifier: Flutemetamol 2
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease; Dementia

Keywords

Mild cognitive impairment; Alzheimer; PET; Amyloid; Frontotemporal

Outcome Measures

Primary Outcomes (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.

  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.

  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 Outcomes (6)

• 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

Study Arms (1)

Flutmetamol Group

EXPERIMENTAL

PET-MR-Scan with 80-140 MBq Flutemetamol before observational period for diagnostic purpose

Drug: Flutemetamol (Vizamyl)

Interventions

Flutemetamol (Vizamyl) DRUG

PET-MR Scan using the radiotracer Flutemetamol (Vizamyl) for diagnostic purpose

Flutmetamol Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• MMSE \>15
• Competency to consent
• Trial partner willing to support study physician
• Written informed consent by both patient and trial partner

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Zurich: lead
• ETH Zurich: collaborator

Study Sites (1)

University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy

Schlieren, Canton of Zurich, 8952, Switzerland

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia

Interventions

flutemetamol

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Christoph Hock, MD, Prof.

  University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 3, 2015
• Study Start: May 1, 2015
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: January 21, 2020

Record last verified: 2020-01

Locations

CH (1)