Overview

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