Clinical trial NCT02353949: Investigating the Clinical Consequences of Flutemetamol-PET-scanning
Official title: Investigating the Clinical Consequences of Flutemetamol-PET-scanning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Mild Cognitive Impairment
Alzheimer's Disease
Dementia
Keywords: Mild cognitive impairment
Alzheimer
PET
Amyloid
Frontotemporal
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ETH Zurich
First posted: 2015-02-03
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

  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

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  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

Primary outcomes:
measure: 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.
timeFrame: Three months after initiation of standard treatment
Secondary outcomes:
measure: 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.
timeFrame: Three months after initiation of standard treatment
measure: 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.
timeFrame: Three months after initiation of standard treatment
measure: 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.
timeFrame: Three months after initiation of standard treatment
Other outcomes:
measure: Comparisons of change from pre-treatment assessment of ADAS-Cog-11 after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status
timeFrame: Six Months after initiation of standard treatment
measure: Comparisons of change from pre-treatment assessment of ADCS-ADL after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status
timeFrame: Six Months after initiation of standard treatment
measure: Comparisons of change from pre-treatment assessment of MMSE after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status
timeFrame: Six Months after initiation of standard treatment
measure: Comparisons of change from pre-treatment assessment of ADCS-CGIC after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status
timeFrame: Six Months after initiation of standard treatment
measure: Change from pre-treatment assessment on the decision regret scale after three months
timeFrame: Three Months after initiation of standard treatment
measure: Change from pre-treatment assessment on the decision regret scale after six months
timeFrame: Six Months after initiation of standard treatment
Locations:
city: Schlieren
country: Switzerland
facility: University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy
state: Zurich
Study officials:
affiliation: University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy
name: Christoph Hock, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: