Efficacy of inflawell capsules on behavioral and cognitive symptoms and DTI changes in patients with frontotemporal dementia
- Conditions
- Frontotemporal dementia.Frontotemporal dementiaG31.0
- Registration Number
- IRCT20170315033086N8
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Behavioral variant of Frontotemporal dementia based on guideline: Rascovsky K, Hodges JR, Knopman D, et al. Sensitivity of revised diagnostic criteria for the behavioural variant of frontotemporal dementia. Brain. 2011;134
Language variant of Frontotemporal dementia based on guideline: Gorno-Tempini ML, Hillis AE, Weintraub S, et al. Classification of primary progressive aphasia and its variants. Neurology. 2011;76:1006-1014
Other specific diseases of the central nervous system such as Parkinson's, multifactorial dementia, anterior brain dementia, Huntington's disease, hydrocephalus, brain tumors confirmed by MRI, severe paralysis of the nerve of the supernuclear body, epilepsy, clots between layers of brain tissue, multiple sclerosis and other dementias
Taking NSAIDs and systemic corticosteroids for previous two months continuously
Severe cardiovascular disease, kidney and liver disorders
Psychiatric disorders include bipolar disorder and schizophrenia under medication
Drugs or alcohol abuse
Brain-related surgical interventions
head trauma and progressive degenerative motor disorder
Metabolic and systemic diseases
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the lesion area of brain. Timepoint: At the commencement of the investigation and 3 months after taking inflawell. Method of measurement: MRI ( Diffusion Tensor Imaging).
- Secondary Outcome Measures
Name Time Method Changes in cognitive and behavioral symptoms. Timepoint: At the commencement of the investigation and 3 months after taking inflawell. Method of measurement: Clinical cognitive tests: Behavioral inventory and FTD-Clinical dementia rating (FTD-CDR), Neuropsychiatry inventory (NPI), Frontal assessment buttery (FAB), Persian naming test (PNT).