Trial | NCT00203359  Report issue

Title

TNF-Alpha Inhibition for Treatment of Alzheimer's Disease
Etanercept for Alzheimer's-Type Memory Loss Pilot Study

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    etanercept ...

  • Study Participants

    15
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.
Etanercept, a biologic anti-TNF fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 15 study subjects for a period of one month, followed by a 5 month and a 6 month possible study extension, with serial testing of cognition and function monthly.
Study Started
Sep 30
2004
Study Completion
Apr 30
2006
Last Update
Apr 24
2006
Estimate

Drug etanercept given by perispinal administration

Criteria 

Inclusion Criteria:

NINCDS-ADRDA Criteria for Alzheimer's disease
CT or MRI consistent with AD

Exclusion Criteria:

active infection
CHF
demyelinating disease
uncontrolled diabetes mellitus
vascular dementia
clinically significant neurologic disease other than AD
Hachinski >4
history of lymphoma
TBC
wbc<2500
platelets<100,000
HCT<30
pregnancy
premenopausal, fertile not on acceptable birth control
change in neuroactive medication within 4 weeks of study initiation
No Results Posted