Focal dementia syndromes - primary aphasia MedDRA version: 14.1 Level: LLT Classification code 10012292 Term: Dementia of the Alzheimer's type NOS System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Florbetapir 18F Solution for Injection
Product Code: 18F-AV-45
Pharmaceutical Form: Injection
INN or Proposed INN: Florbetapir (18F)
Sponsors
Avid Radiopharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PPA Group 1. Are currently enrolled in the longitudinal study of frontotemporal lobular degeneration at the Dementia Research Centre (DRC) at UCL 2. Patients with PPA will have undergone detailed neuropsychological assessments and will be classified in one of three syndromic groups:PNFA, LPA, or SD 3. Can tolerate a PET scan procedure PCA-AD Group 1. Are currently enrolled in the longitudinal study of frontotemporal lobular degeneration at the Dementia Research Centre (DRC) 2. Patients with PCA-AD will have undergone detailed neurological assessments and will fulfil the following criteria: 1) insidious onset of cognitive decline, sufficient to interfere with activities of daily living, with absence of structural lesion or significant whilte matter disease on MRI. 2) relatively preserved episodic memory; deficits on standard psychological testing in at least two of four posterior cortical functions: (a) object perception (b) space perception (c) calculation (d) spelling 3. can tolerate a PET scan procedure Cognitively normal group 1. have no cognition complaints 2. are between 55 and 90 years of age 3. give informed consent 4. can tolerate a PET scan procedure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Have clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances 2. Have a clinically significant cardiovascular disease 3. Have a clinically significant infectious disease 4. Have a history of alcohol or substance abuse or dependence 5. Have a history of severe drug allergy or hypersensitivity 6. Women of child bearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Use florbetapir 18F PET imaging to investigate the pathological underpinning of the neuropsychologically distinct variants of progressive aphasia and compare these patterns of florbetapir 18F uptake with "typical" Alzheimer's disease and age-matched controls;Secondary Objective: To investigate associations between focal brain atrophy, cortical thickness and regional amyloid uptake in amyloid positive variants of these syndromes;Primary end point(s): Quantitative and qualitative assessments of florbetapir 18F uptake to test the primary hypotheses;Timepoint(s) of evaluation of this end point: Complete imaging of all subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Descriptive assessment of the focality and asymmetry of amyloid uptake and glucose hypometabolism between various groups;Timepoint(s) of evaluation of this end point: Complete imaging of all subjects | — |
Countries
United Kingdom
Contacts
Public ContactRegulatory Affairs Department
Akos, Ltd.
Outcome results
None listed