NCT00470418

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 alzheimer-disease

Timeline
Completed

Started Jan 2007

Typical duration for phase_2 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

January 9, 2017

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

May 4, 2007

Results QC Date

January 16, 2014

Last Update Submit

January 5, 2017

Conditions

Alzheimer DiseaseDementia

Keywords

Alzheimer DiseaseAlzheimer Type Senile DementiaAlzheimer's Diseaseclinical trialdementiadiabetesdietary supplementsSenile Dementia, Alzheimer TypeTherapeutics

Outcome Measures

Primary Outcomes (1)

  • Safety Assessments: Number of Participants With Adverse Events

    vital signs, physical exam, Symptom Checklist, complete blood count, serum chemistries, urinalysis, and electrocardiogram

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

Secondary Outcomes (1)

  • Changes From Baseline in Clinical Measures of Cognition at Terminal Visit

    baseline and six weeks

Study Arms (2)

NIC5-15

OTHER

Subjects with Alzheimer's Disease

Drug: NIC5-15

Placebo

PLACEBO COMPARATOR

Subjects with Alzheimer's Disease

Drug: Placebo

Interventions

NIC5-15DRUG

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

Also known as: d-Pinitol
NIC5-15
PlaceboDRUG

placebo comparator

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementiaDiabetes Mellitus

Interventions

pinitol

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Hillel Grossman
Organization
James J Peters VA Medical Center
hillel.grossman2@va.gov
718-584-9000

Study Officials

  • Hillel Grossman, MD

    VA Medical Center, Bronx

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2007

First Posted

May 7, 2007

Study Start

January 1, 2007

Primary Completion

August 1, 2008

Study Completion

March 1, 2010

Last Updated

January 9, 2017

Results First Posted

January 9, 2017

Record last verified: 2017-01

Locations

US(1)