Alzheimer's Disease
Conditions
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.
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.
Interventions
Sponsors
Tobinick, Edward Lewis, M.D.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-Cog | — |
| SIB | — |
| MMSE | — |
| ADCS-ADLsev | — |
Secondary
| Measure | Time frame |
|---|---|
| Category fluency | — |
Countries
United States
Outcome results
None listed