Florbetapir F18 (18F-AV-45) amyloid positron emission tomography (PET) imaging in focal dementia syndromes

Phase 2

Completed

• Conditions: Focal dementia syndromes - primary aphasia; Mental and Behavioural Disorders; Multi-infarct dementia

• Registration Number: ISRCTN57388990
• Lead Sponsor: Avid Radiopharmaceuticals Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-08
• Study Completion: 2012-11-17
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

PPA Group
1. Are currently enrolled in the longitudinal study of frontotemporal lobular degeneration at the Dementia Research Centre (DRC) at University College London (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. 1.Are currently enrolled in the longitudinal study of posterior cortical atrophy at the Dementia Research Centre (DRC)
2. Patients with PCA-AD will have undergone detailed neurological assessments and will fulfil the following criteria:
2.1. Insidious onset of cognitive decline, sufficient to interfere with activities of daily living, with absence of structural lesion or significant whilte matter disease on magnetic resonnace imaging (MRI)
2.2. Relatively preserved episodic memory; deficits on standard psychological testing in at least two of four posterior cortical functions:
2.2.1. Object perception
2.2.2. Space perception
2.2.3. Calculation
2.2.4. 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

Participants may be male or female.
Subjects in the cognitively normal group must be aged 55 ?- 90 years.
Female subjects in the PPA and PCA-AD groups must be over 55 years and not have child bearing potential; male subjects may be younger.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative and qualitative assessments of florbetapir 18F uptake to test the primary hypotheses

Secondary Outcome Measures

Name	Time	Method
Descriptive assessment of the focality and asymmetry of amyloid uptake and glucose hypometabolism between various groups