A Single Site, Randomized, Double-blind, Placebo Controlled Trial of NIC5-15 in Subjects With Alzheimer's Disease

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Humanetics Corporation
• Collaborators: James J. Peters Veterans Affairs Medical Center; National Center for Complementary and Integrative Health (NCCIH)

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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 or past treatment with insulin for longer than two weeks

• Current use of drugs with significant anticholinergic or antihistaminic properties