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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57388990
Enrollment
25
Registered
2011-11-08
Start date
2011-11-17
Completion date
Unknown
Last updated
2018-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal dementia syndromes - primary aphasia Mental and Behavioural Disorders Multi-infarct dementia

Interventions

A single 300 MBq bolus injection of florbetapir F 18 will be administered to the patient 50 minutes prior to PET scan of the brain. Subjects are observed for 70 minutes after injection and a follow-up

Sponsors

Avid Radiopharmaceuticals Inc. (USA)
Lead Sponsor

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 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

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

MeasureTime frame
Quantitative and qualitative assessments of florbetapir 18F uptake to test the primary hypotheses

Secondary

MeasureTime frame
Descriptive assessment of the focality and asymmetry of amyloid uptake and glucose hypometabolism between various groups

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026