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CompletedPhase 2

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

Lead sponsor

Humanetics Corporation

Asset

NIC5-15

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-27•AD symptomatic therapy: stable ≥12 weeks

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Other grantMHBB-009-06SDepartment of Veterans Affairs

NCT IDNCT01928420

Org study IDNCT01928420

Timeline

Milestones

Study start2007-04 (month precision)

Study first posted2013-08-26estimated

Primary completion2014-06actual (month precision)

Study completion2014-06actual (month precision)

Last update posted2016-10-17estimated

Assets

Drug assets

NIC5-15

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Global cognition

Memory

Function / daily living

Behavior / neuropsychiatric

Amyloid biomarkers

Other (unclassified)

Global cognition

2 endpoints

Primary/protocol endpoint

Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score

Time frame:Over 6 months, measured at visits 2 (week 2), 6 (week 12), 8 (week 24)

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in Mini-Mental State Examination (MMSE) Score

Time frame:Over 6 months, measured at visits 2 (week 2), 6 (week 12), 8 (week 24)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Memory

1 endpoint

Secondary/protocol endpoint

APO-E genotyping

Time frame:Collected at visit 2 (week 2)

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Score

Time frame:Over 6 months, measured at visits 2 (week 2), 6 (week 12), 8 (week 24)

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Change in Neuropsychiatric Inventory (NPI) Score

Time frame:Over 6 months, measured at visits 2 (week 2), 6 (week 12), 8 (week 24)

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Changes in AD Biomarkers

Time frame:Blood collected at visits 2 (week 2), 6 (week 12), 8 (week 24)

descriptive

Safety / tolerability / PK

5 endpoints

Other/protocol endpoint

Symptoms Checklist and Adverse Event Assessment

Time frame:6 Months, conducted at visits 3 (week 2), 4 (week 4), 5 (week 8), 6 (week 12), 7 (week 18), 8 (week 24)

event count, event

Other/protocol endpoint

Safety Laboratory Assessments

Time frame:6 Months, conducted at visits 1 (week 1), 3 (week 2), 4 (week 4), 5 (week 8), 6 (week 12), 7 (week 18), 8 (week 24)

descriptive

Other/protocol endpoint

Neurological examination

Time frame:6 Months, conducted at visits 1 (week 1), 6 (week 12), 8 (week 24)

descriptive

Other/protocol endpoint

Physical examination

Time frame:6 Months, conducted at visits 1 (week 1), 3 (week 2), 5 (week 8), 6 (week 12), 7 (week 18), 8 (week 24)

ratio, event

Other/protocol endpoint

Pharmacokinetic analysis

Time frame:6 Months, conducted at visits 2 (week 2), 8 (week 24)

concentration, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in Alzheimer's Disease Cooperative Study Clinician's Global Impression of Change (ADCS-CCGIC) Score

Time frame:Over 6 months, measured at visits 2 (week 2), 6 (week 12), 8 (week 24)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.