TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

Etanercept for Alzheimer's-Type Memory Loss Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203359
• Other study ID #: 10005
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: April 20, 2006
• Start date: September 2004
• Est. completion date: April 2006

Study information

• Verified date: April 2006
• Source: Tobinick, Edward Lewis, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• etanercept given by perispinal administration

Locations

Country	Name	City	State
United States	Edward Tobinick, MD (private medical office)	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Tobinick, Edward Lewis, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADAS-Cog
Primary	SIB
Primary	MMSE
Secondary	Category fluency
Secondary	other neuropsychological tests