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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease, Dementia

In brief

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

Key facts

Study ID

NCT01928420

Run by

Humanetics Corporation

People needed

30

Starts

2007-04-01

Expected to finish

2014-06-01

Last updated by the study team

2016-10-17

Who can join

Age: 40 and older, up to 95. 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 or past treatment with insulin for longer than two weeks
• Current use of drugs with significant anticholinergic or antihistaminic properties

Where it is running

• James J Peters Veterans Affairs Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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