A PLACEBO CONTROLLED, RANDOMIZED DOUBLE-BLIND PARALLEL GROUP 12-MONTH TRIAL OF FASUDIL FOR THE TREATMENT OF EARLY ALZHEIMER’S DISEASE (FEAD)

Conditions

Alzheimer's disease

Brief summary

The primary outcome will be the FLAME computer-based working memory composite, specifically the change over 12 months

Detailed description

Using FLAME battery to assess speed of attention, accuracy of attention and executive function, Measure the extension and severity of the AD hypometabolic pattern at FDG-PET, Safety data will be collected through measurements of vital signs, weight, physical and neurological examination, clinical safety laboratory tests, ECG, and suicidality, Changes in CSF Aβ1-40, Aβ1-42, tau and p-tau and blood plasma ptau217, Nfl and other relevant markers of neurodegeneration will be assessed over 12 months., Ability to perform everyday activities, and changes in functionality: Activities of daily living assessments using the Amsterdam ADL scale, Overall clinical condition: Clinical Global Impression of Change, Severity of dementia symptoms: Clinical Dementia Rating (CDR)-sum of boxes, Neuropsychiatric symptoms and behaviors Neuropsychiatric Inventory (NPI-Q), Quality of life assessments using the DEMQOL and a short assessment of health-related costs using the EQ-5D questionnaire

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGFasudil Hyrdrochloride

DRUGFasudil Hydrochloride

DRUGPlacebo capsule to match 40 mg fasudil

DRUGPlacebo capsule to match 20 mg fasudil

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary outcome will be the FLAME computer-based working memory composite, specifically the change over 12 months	—

Secondary

Measure	Time frame
Using FLAME battery to assess speed of attention, accuracy of attention and executive function, Measure the extension and severity of the AD hypometabolic pattern at FDG-PET, Safety data will be collected through measurements of vital signs, weight, physical and neurological examination, clinical safety laboratory tests, ECG, and suicidality, Changes in CSF Aβ1-40, Aβ1-42, tau and p-tau and blood plasma ptau217, Nfl and other relevant markers of neurodegeneration will be assessed over 12 months., Ability to perform everyday activities, and changes in functionality: Activities of daily living assessments using the Amsterdam ADL scale, Overall clinical condition: Clinical Global Impression of Change, Severity of dementia symptoms: Clinical Dementia Rating (CDR)-sum of boxes, Neuropsychiatric symptoms and behaviors Neuropsychiatric Inventory (NPI-Q), Quality of life assessments using the DEMQOL and a short assessment of health-related costs using the EQ-5D questionnaire	—

Measure

Time frame

Using FLAME battery to assess speed of attention, accuracy of attention and executive function, Measure the extension and severity of the AD hypometabolic pattern at FDG-PET, Safety data will be collected through measurements of vital signs, weight, physical and neurological examination, clinical safety laboratory tests, ECG, and suicidality, Changes in CSF Aβ1-40, Aβ1-42, tau and p-tau and blood plasma ptau217, Nfl and other relevant markers of neurodegeneration will be assessed over 12 months., Ability to perform everyday activities, and changes in functionality: Activities of daily living assessments using the Amsterdam ADL scale, Overall clinical condition: Clinical Global Impression of Change, Severity of dementia symptoms: Clinical Dementia Rating (CDR)-sum of boxes, Neuropsychiatric symptoms and behaviors Neuropsychiatric Inventory (NPI-Q), Quality of life assessments using the DEMQOL and a short assessment of health-related costs using the EQ-5D questionnaire

—

Countries

Norway

Outcome results

None listed