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

NCT01928420 | Completed Phase 2 DMC

• 3 other identifiers: NCT01928420R21AT003302-01A1MHBB-009-06S
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease; Dementia

Keywords

Alzheimer Disease; Alzheimer Type Senile Dementia; Alzheimer's Disease; clinical trial; dementia; diabetes; dietary supplements; Senile Dementia, Alzheimer; Therapeutics; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Delirium, Dementia, Amnestic, Cognitive; Disorders; Mental Disorders

Outcome Measures

Primary Outcomes (1)

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

  A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.

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

Secondary Outcomes (6)

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

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

• Change in Mini-Mental State Examination (MMSE) Score

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

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

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

• Change in Neuropsychiatric Inventory (NPI) Score

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

• Changes in AD Biomarkers

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

Other Outcomes (5)

• Symptoms Checklist and Adverse Event Assessment

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

• Safety Laboratory Assessments

  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)

• Neurological examination

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

Study Arms (2)

NIC5-15

EXPERIMENTAL

Subjects with Alzheimer's Disease Intervention: Drug: NIC5-15

Drug: Drug: NIC5-15

Placebo

PLACEBO COMPARATOR

Subjects with Alzheimer's Disease Intervention: Drug: Placebo

Drug: Placebo

Interventions

Drug: NIC5-15 DRUG

A natural product, found in many foods and plants with mild insulin sensitizing effects

Also known as: Pinitol

NIC5-15

Placebo DRUG

Subjects with Alzheimer's Disease placebo comparator

Placebo

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Humanetics Corporation: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• James J. Peters Veterans Affairs Medical Center: collaborator

Study Sites (1)

James J Peters Veterans Affairs Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Diabetes Mellitus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Delirium; Disease; Mental Disorders

Interventions

pinitol

Condition Hierarchy (Ancestors)

Tauopathies; Neurocognitive Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Hillel Grossman, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2012
• First Posted: August 26, 2013
• Study Start: April 1, 2007
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

US (1)