Development of NIC5-15 in the Treatment of Alzheimer's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease, Dementia

In brief

The purpose of this study is to evaluate the safety and efficacy of NIC5-15in the treatment of Alzheimer's Disease.

Key facts

Study ID

NCT00470418

Run by

VA Office of Research and Development

People needed

15

Starts

2007-01-01

Expected to finish

2010-03-01

Last updated by the study team

2017-01-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Medical Center, Bronx — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.