Phase 2
Completed N=10
Development of NIC5-15 in the Treatment of Alzheimer's Disease
Source: ClinicalTrials.gov NCT00470418 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Safety Assessments: Number of Participants With Adverse Events — 07; 02 Participants
Summary
The purpose of this study is to evaluate the safety and efficacy of NIC5-15in the treatment of Alzheimer's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Assessments: Number of Participants With Adverse Events |
07; 02 | — |
| SECONDARY Changes From Baseline in Clinical Measures of Cognition at Terminal Visit |
.8; -5.3; 2; 5.3; 1; 1.7 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00470418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.