The primary aim of the study is to determine the safety and tolerability of etanercept in subjects with Alzheimer's Disease. The effects of etanercept on cognitive, behavioural, functional and immunological outcomes will be examined as secondary aims.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
41
50 mg given as a once weekly subcutaneous injection
Placebo injection given once weekly
Memory Assessment and Research Centre, Moorgreen Hospital
Southampton, Hampshire, United Kingdom
Frequency of adverse events and serious adverse events (the study is a Phase II safety trial)
Time frame: 6 months
Difference in change in Alzheimer's Disease Assessment Scale - Cognitive Section (ADAS-cog) total score between treated and placebo groups from baseline to end point at 6 months
Time frame: 6 months
Difference in change in Neuropsychiatric Inventory (NPI) total score between treated and placebo groups from baseline to end point at 6 months
Time frame: 6 months
Difference in change in Clinician's Global Impression of Change (CGIC) and Carer's Impression of Change (Carer-IC) total score between treated and placebo groups from baseline to end point at 6 months
Time frame: 6 months
Difference in change in Mini-Mental State Examination (MMSE) total score between treated and placebo groups from baseline to end point at 6 months
Time frame: 6 months
Difference in change in Sickness Behaviour Scale between treated and placebo groups from baseline to end point at 6 months
Time frame: 6 months
To establish whether a pro-inflammatory baseline cytokine profile predicts better response to treatment with etanercept
Time frame: 6 months
To examine the effects of etanercept on inflammatory markers in the cerebrospinal fluid (CSF) of patients with Alzheimer's disease, and the relationship of these factors with clinical outcome
Time frame: 6 months
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