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Completed

NCT Number: NCT00203320

TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

100 UCLA Medical Plaza, Suites 205-210

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept given by perispinal administration

Drug

Primary outcomes

  1. ADAS-Cog

  2. SIB

  3. MMSE

  4. ADCS-ADLsev

Secondary outcomes

  1. Category fluency

Sponsors and collaborators

Lead sponsor

Tobinick, Edward Lewis, M.D.

Other

Registry information

Official study title

Etanercept for Alzheimer's-Type Memory Loss Pilot Study II

Important dates

Study start
2005
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Apr 24, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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