TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-01-31

Brief Summary

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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

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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etanercept given by perispinal administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Edward L. Tobinick, M.D.

Role: PRINCIPAL_INVESTIGATOR

unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA)

Locations

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100 UCLA Medical Plaza, Suites 205-210

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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10007

Identifier Type: -

Identifier Source: org_study_id