Investigating the Clinical Consequences of Flutemetamol-PET-scanning

Dementia Clinical Trial

Official title:

Investigating the Clinical Consequences of Flutemetamol-PET-scanning

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02353949
• Other study ID #: Flutemetamol 2
• Status: Terminated
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: December 10, 2019

Study information

• Verified date: January 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Switzerland	University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy	Schlieren	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	ETH Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Change from pre-treatment assessment on the decision regret scale after three months		Three Months after initiation of standard treatment
Other	Change from pre-treatment assessment on the decision regret scale after six months		Six Months after initiation of standard treatment
Primary	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	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
Secondary	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
Secondary	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