ISRCTN58435532
Completed
Phase 2
A study evaluating the imaging characteristics of florpiramine F 18 (18F-AV-45) in patients with frontotemporal dementia compared to patients with Alzheimer's disease and normal controls
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Frontotemporal dementia and Alzheimer's disease
- Sponsor
- Avid Radiopharmaceuticals Inc.
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who meet all of the following criteria are eligible to enrol in the arm of this trial reserved for patients with probable AD:
- •1\. Male or female patients, at least 50 years of age, with probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS)/Alzheimer's Disease and Related Disorders Association (ADRDA) criteria
- •2\. Patients with mild/moderate dementia as evidenced by a Mini\-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
- •3\. Patients whose history of cognitive decline has been gradual in onset and progressive over a period of at least 6 months. Evidence should be present indicating sustained memory deterioration in an otherwise cognitively normal patient, plus additional impairment in another cognitive function such as: orientation, judgment and problem solving, or functioning in personal care.
- •4\. Patients who live with or have regular visits from a responsible caregiver willing to provide information about the patient
- •5\. Patients who give informed consent by signing a UK Multicentre Research Ethics Committee (MREC) approved informed consent prior to any study procedures. If the patient is incapable of giving informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent). The consent procedure will be performed in accordance with the Mental Capacity Act 2005\.
- •Subjects who meet all of the following criteria are eligible to enrol in the arm of this trial reserved for patients with FTD:
- •1\. Males or females at least 45 years of age
- •2\. Meet the consensus criteria for frontotemporal lobar degeneration and have mild to moderate disease severity. Clinical and neuropsychological criteria will be applied and will include only patients with the clinical phenotypes of behavioural\-dysexecutive FTD. Clinical and neuropsychological features are obligatory, while patients can also be included if structural imaging findings are supportive of the diagnosis or neutral (not suggesting an alternative diagnosis). Functional imaging findings will not be considered prior to patient inclusion.
- •3\. Have a caregiver who can report on their mental status and Activities of Daily Living (ADL)
Exclusion Criteria
- •1\. Neurodegenerative disorders other than AD or FTD as appropriate, including, but not limited to Parkinson's disease, Huntington's disease, Down's syndrome, Creutzfeldt\-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
- •2\. Have now or have had a diagnosis of other dementing/neurodegenerative disease (e.g. Parkinson's disease, dementia with Lewy bodies, Lewy body variant AD, etc.)
- •3\. Have now or have had a diagnosis of mixed dementia
- •4\. Cognitive impairment or significant residual findings on magnetic resonance imaging (MRI) resulting from:
- •4\.1\. Acute cerebral trauma or post\-traumatic brain injury, subdural haematoma, or injuries secondary to chronic trauma (e.g., sequella from boxing)
- •4\.2\. Hypoxic cerebral damage regardless of aetiology; e.g., cognitive or neurological deficits resulting from cardiac arrest or cardiac surgery, anaesthesia, or severe self\-poisoning episode, secondary to severe hypovolaemia (orthostatic hypotension should not lead to exclusion)
- •4\.3\. Vitamin deficiency states documented by medical history such as folate, vitamin B12 and other B complex deficiencies; e.g., thiamine deficiency in Korsakoff's syndrome (patients taking regular B12 and folate are not necessarily excluded)
- •4\.4\. Cerebral infection including abscess, syphilis, meningitis, encephalitis or acquired immune deficiency syndrome (AIDS)
- •4\.5\. Primary or metastatic cerebral neoplasia
- •4\.6\. Significant endocrine or metabolic disease; e.g., thyroid, parathyroid, or pituitary disease, Cushing's syndrome, or severe renal failure
Outcomes
Primary Outcomes
Not specified
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