Back to resultsTNF-Alpha Inhibition for Treatment of Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
etanercept given by perispinal administration
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility 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
Sites / Locations
- 100 UCLA Medical Plaza, Suites 205-210
Outcomes
Primary Outcome Measures
ADAS-Cog
SIB
MMSE
ADCS-ADLsev
Secondary Outcome Measures
Category fluency
Full Information
NCT ID
NCT00203320
First Posted
September 12, 2005
Last Updated
April 20, 2006
Sponsor
Tobinick, Edward Lewis, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT00203320
Brief Title
TNF-Alpha Inhibition for Treatment of Alzheimer's Disease
Official Title
Etanercept for Alzheimer's-Type Memory Loss Pilot Study II
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tobinick, Edward Lewis, M.D.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
etanercept given by perispinal administration
Primary Outcome Measure Information:
Title
ADAS-Cog
Title
SIB
Title
MMSE
Title
ADCS-ADLsev
Secondary Outcome Measure Information:
Title
Category fluency
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward L. Tobinick, M.D.
Organizational Affiliation
unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
100 UCLA Medical Plaza, Suites 205-210
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
TNF-Alpha Inhibition for Treatment of Alzheimer's Disease
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