Skip to main content
Clinical Trials/NCT00203359
NCT00203359
Completed
Phase 1

Etanercept for Alzheimer's-Type Memory Loss Pilot Study

Tobinick, Edward Lewis, M.D.1 site in 1 country15 target enrollmentSeptember 2004

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
Tobinick, Edward Lewis, M.D.
Enrollment
15
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 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.

Registry
clinicaltrials.gov
Start Date
September 2004
End Date
April 2006
Last Updated
20 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Tobinick, Edward Lewis, M.D.

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

Secondary Outcomes

  • other neuropsychological tests
  • Category fluency

Study Sites (1)

Loading locations...

Similar Trials