A Phase 2, Double-blind, Placebo-controlled Study of the Safety and Tolerability of Etanercept in Patients With Alzheimer's Disease

University of Southampton1 site in 1 country41 target enrollmentJanuary 2011

ConditionsAlzheimer's Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: University of Southampton
Enrollment: 41
Locations: 1
Primary Endpoint: Frequency of adverse events and serious adverse events (the study is a Phase II safety trial)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

December 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Southampton

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients aged \> 54 years
•Have a minimum of 7 years of education
•Be able to hear, read, write and perform study neuropsychological tests in English
•Have adequate visual and auditory acuity to allow neuropsychological testing based on the research clinician's judgement
•Fulfil Diagnostic \& Statistical Manual (DSM-IV-TR)criteria for diagnosis of dementia of the Alzheimer type
•Have a diagnosis of probable Alzheimer's Disease (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria)
•Mini Mental State Examination (MMSE) score \< 27 and \> 10 points.
•To be currently taking and have been taking a cholinesterase inhibitor for a minimum period of 3 months prior to the day of inclusion into the study or to have been not been taking a cholinesterase inhibitor for a minimum period of 3 months prior to the day of inclusion into the study
•Have an informant who spends at least 24 hours per week with the patient and may be a close friend or a neighbour, not necessarily a close relative, spouse, son or daughter. He/she should be the same throughout the study and should be present at all visits. If it becomes necessary, a change of informant can be made but this must be clearly documented.

Exclusion Criteria

•Inability or refusal to provide informed consent from patient or caregiver
•Absence of informant
•Unlikely to cooperate in the study, not able to attend scheduled examinations and visits, or not able to follow study instructions
•Participation in another study with administration of any investigational drug in the previous 3 months or already enrolled in another study
•Parkinson's Disease, Dementia with Lewy Bodies or clinically significant Parkinsonian symptoms
•Vascular disorder (modified Hachinski Ischaemic Scale score \> 4)
•Recent Transient Ischaemic Attack (TIA) - within the last 3 months
•Signs of major cerebrovascular disease on MRI or CT scan, if performed prior to entry into study (i.e. presence of infarction in greater than 25% of white matter, more than 1 lacune within basal ganglia, more than 2 lacunes in white matter)
•Any other previous or ongoing chronic or recurrent disease of the central nervous system, including demyelinating disease or psychiatric diseases, that may have an impact on cognitive performance, left to the research clinician's judgement
•Any of the following laboratory abnormalities at the screening visit:

Outcomes

Primary Outcomes

Frequency of adverse events and serious adverse events (the study is a Phase II safety trial)

Time Frame: 6 months

Secondary Outcomes

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(6 months)
Difference in change in Neuropsychiatric Inventory (NPI) total score between treated and placebo groups from baseline to end point at 6 months(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(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(6 months)
Difference in change in Sickness Behaviour Scale between treated and placebo groups from baseline to end point at 6 months(6 months)
To establish whether a pro-inflammatory baseline cytokine profile predicts better response to treatment with etanercept(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(6 months)