NCT00203320
Completed
Phase 1
Etanercept for Alzheimer's-Type Memory Loss Pilot Study II
Tobinick, Edward Lewis, M.D.1 site in 1 country30 target enrollmentApril 2005
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease
- Sponsor
- Tobinick, Edward Lewis, M.D.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- MMSE
- Status
- Completed
- Last Updated
- 20 years ago
Overview
Brief Summary
It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised to be of potential benefit for treating AD.
Detailed Description
Etanercept, a biologic anti-TNF fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 30 study subjects for a period of one year with serial testing of cognition and function.
Investigators
Eligibility Criteria
Inclusion Criteria
- •NINCDS-ADRDA Criteria for Alzheimer's disease
- •CT or MRI consistent with AD
Exclusion Criteria
- •active infection
- •demyelinating disease
- •uncontrolled diabetes mellitus
- •vascular dementia
- •clinically significant neurologic disease other than AD
- •Hachinski \>4
- •history of lymphoma
- •wbc\<2500
- •platelets\<100,000
- •pregnancy
Outcomes
Primary Outcomes
MMSE
ADAS-Cog
SIB
ADCS-ADLsev
Secondary Outcomes
- Category fluency
Study Sites (1)
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