NCT00203320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

April 24, 2006

Status Verified

April 1, 2006

First QC Date

September 12, 2005

Last Update Submit

April 20, 2006

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (4)

  • ADAS-Cog

  • SIB

  • MMSE

  • ADCS-ADLsev

Secondary Outcomes (1)

  • Category fluency

Interventions

etanercept given by perispinal administrationDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • NINCDS-ADRDA Criteria for Alzheimer's disease
  • CT or MRI consistent with AD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

100 UCLA Medical Plaza, Suites 205-210

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Edward L. Tobinick, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2005

Study Completion

January 1, 2006

Last Updated

April 24, 2006

Record last verified: 2006-04

Locations

US(1)