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CompletedPhase 2Results posted

Development of NIC5-15 in the Treatment of Alzheimer's Disease

Lead sponsor

VA Office of Research and Development

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

•Safety Assessments

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

Org study IDMHBB-009-06S

NCT IDNCT00470418

NihR21AT003302-01A1

Timeline

Milestones

Study start2007-01 (month precision)

Study first posted2007-05-07estimated

Primary completion2008-08actual (month precision)

Study completion2010-03actual (month precision)

Last update posted2017-01-09estimated

Results first posted2017-01-09estimated

Assets

Drug assets

NIC5-15

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

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 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

Endpoints (4)

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

Global cognition

Safety / tolerability / PK

Global cognition

2 endpoints

Secondary/protocol endpoint

Changes From Baseline in Clinical Measures of Cognition at Terminal Visit

Time frame:baseline and six weeks

ADAS-Cog

categorical status, descriptive

Secondary/registry result

Changes From Baseline in Clinical Measures of Cognition at Terminal Visit

Time frame:baseline and six weeks

ADAS-Cog

categorical status, descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
NIC5-15MMSEn=7 Participants	.8	1.02
ADAS-cogn=7 Participants	2	2.1
ADCS-ADLsn=7 Participants	1	2.8
PlaceboMMSEn=3 Participants	-5.3	6.4
ADAS-cogn=3 Participants	5.3	3.2
ADCS-ADLsn=3 Participants	1.7	7.4

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Safety Assessments: Number of Participants With Adverse Events

Time frame:Safety Labs, Physical Exams: 6 times over 7 weeks. Adverse Events assessed 21 times over the course of 7 weeks

event count, event

Primary/registry result

Safety Assessments: Number of Participants With Adverse Events

Time frame:Safety Labs, Physical Exams: 6 times over 7 weeks. Adverse Events assessed 21 times over the course of 7 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
NIC5-15n=7 Participants	07	-
Placebon=3 Participants	02	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.