TNF-Alpha Inhibition for Treatment of Alzheimer's Disease | NCT00203359

Studies
TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

NCT00203359

Sponsor

Tobinick, Edward Lewis, M.D.

Status

Completed

Last Update Posted

Apr 24, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

etanercept given by perispinal administration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Apr 2006

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2006

Last Update Posted Date

Apr 24, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
etanercept given by perispinal administration	Drug

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edward L Tobinick, MD	unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Edward Tobinick, MD (private medical office)		Los Angeles	California	90095	United States

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
ADAS-Cog
SIB
MMSE

Measure	Description	Time Frame
Category fluency
other neuropsychological tests