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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

etanercept given by perispinal administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Edward L Tobinick, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Edward Tobinick, MD (private medical office)

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10005

Identifier Type: -

Identifier Source: org_study_id