Investigating the Clinical Consequences of Flutemetamol-PET-scanning

University of Zurich (UZH)

Status and phase: Terminated; Phase 3

Conditions: Alzheimer's Disease; Mild Cognitive Impairment; Dementia

Treatments: Drug: Flutemetamol (Vizamyl)

Study type: Interventional

Funder types: Other

Identifiers

NCT02353949

Flutemetamol 2

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Flutmetamol Group

Experimental group

Description:

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

Treatment:

Drug: Flutemetamol (Vizamyl)