Status:
COMPLETED
Development of NIC5-15 in the Treatment of Alzheimer's Disease
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Humanetics Corporation
Conditions:
Alzheimer Disease
Dementia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of NIC5-15in the treatment of Alzheimer's Disease.
Detailed Description
Recent epidemiologic evidence, has suggested that diabetes mellitus significantly increases risk for the development of Alzheimer's disease, independent of vascular risk factors. Moreover, even patien...
Eligibility Criteria
Inclusion
- NINCDS/ADRDA criteria for probable AD
- MMSE between 12-27
- Treatment with a cholinesterase inhibitor or an NMDA (N-methyl-D-asparate) antagonist with stable dose for at least 12 weeks
- Home monitoring available for supervision of medications
- Caregiver available to accompany patient to all visits and willing to participate in study as informant
- Fluent in English or Spanish
- Medical stability for this study as confirmed by review of records, internist's physical exam, neurological exam, and laboratory tests
- Stable doses of non-excluded medication
- No evidence of hepatic insufficiency
- Able to swallow oral medications
- Ability to participate in the informed consent process
Exclusion
- History of Diabetes Mellitus (OGTT criteria) requiring treatment with an excluded antidiabetic medication (see below) or history of hypoglycemia
- Active hepatic or renal disease
- Cardiac disease including history of congestive heart failure or current treatment for CHF; history of recent myocardial infarction
- Use of another investigational drug within the past two months
- History of clinically significant stroke
- History of seizure or head trauma with disturbance of consciousness within the past two years
- Major mental illness including psychotic disorders, bipolar disorder, or major depressive episode within the past two years Medication Exclusion
- Current use of oral hypoglycemic agents including sulfonylureas and meglintinides
- Current use of a lipid-lowering agent (excluded from Study #1, see discussion below)
- Current or past treatment with insulin for longer than two weeks
- Current use of drugs with significant anticholinergic or antihistaminic properties
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00470418
Start Date
January 1 2007
End Date
March 1 2010
Last Update
January 9 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Medical Center, Bronx
The Bronx, New York, United States, 10468