Alzheimer's DiseasePhase 1NCT00203320
TNF-Alpha Inhibition for Treatment of Alzheimer's Disease
A Phase 1 study testing etanercept given by perispinal administration in people with Alzheimer's Disease, run by Tobinick, Edward Lewis, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- etanercept given by perispinal administration
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jan 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- NINCDS-ADRDA Criteria for Alzheimer's disease
- CT or MRI consistent with AD
Who cannot join
- active infection
- CHF
- demyelinating disease
- uncontrolled diabetes mellitus
- vascular dementia
- clinically significant neurologic disease other than AD
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
100 UCLA Medical Plaza, Suites 205-210
Los Angeles, California, 90095
About this study
Official title: Etanercept for Alzheimer's-Type Memory Loss Pilot Study II
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.
Read the detailed description
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
- Alzheimer's Disease
- Being tested
- etanercept given by perispinal administration
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanercept given by perispinal administrationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-Cog
SIB
MMSE
ADCS-ADLsev
Secondary outcomes (1)
Category fluency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Tobinick, Edward Lewis, M.D.
- Sponsor type
- University, hospital or other
- Investigators
- Edward L. Tobinick, M.D., Principal investigator, unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203320
- Sponsor's protocol ID
- 10007
- Status last verified
- Apr 2006
- First submitted
- 12 Sep 2005
- Last updated
- 24 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etanercept for Alzheimer's-Type Memory Loss Pilot Study II
- ClinicalTrials.gov ID
- NCT00203320
- Acronym / sponsor ID
- 10007
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Tobinick, Edward Lewis, M.D.University, hospital or other
- Study start
- Apr 2005
- Study completion
- Jan 2006
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 30 study subjects for a period of one year with serial testing of cognition and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- NINCDS-ADRDA Criteria for Alzheimer's disease
- CT or MRI consistent with AD
Key exclusion criteria (15 listed)
- active infection
- CHF
- demyelinating disease
- uncontrolled diabetes mellitus
- vascular dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etanercept given by perispinal administration | Drug | – |
Primary outcome
ADAS-Cog
SIB
MMSE
ADCS-ADLsev
1 secondary outcome
Category fluency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward L. Tobinick, M.D. principal investigator
unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing etanercept given by perispinal administration in people with Alzheimer's Disease, run by Tobinick, Edward Lewis, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-Cog. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2006.