ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00470418
Recruitment Status : Completed
First Posted : May 7, 2007
Results First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Humanetics Corporation
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alzheimer Disease
Dementia
Interventions Drug: NIC5-15
Drug: Placebo
Enrollment 15

Recruitment Details  
Pre-assignment Details 5 subjects did not meet entry criteria and were not baselined
Arm/Group Title NIC5-15 Placebo
Hide Arm/Group Description

NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects. Subjects received escalating doses of 1500, 3000 and 5000 mg daily over the course of the study.

Subjects with Alzheimer's Disease

Placebo: placebo comparator identical in pill size, appearance and number

Subjects with Alzheimer's Disease

Period Title: Overall Study
Started 7 3
Completed 6 3
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title NIC5-15 Placebo Total
Hide Arm/Group Description

Subjects with Alzheimer's Disease

NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects

Subjects with Alzheimer's Disease

Placebo: placebo comparator

Total of all reporting groups
Overall Number of Baseline Participants 7 3 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 3 participants 10 participants
70.4  (12.5) 69.7  (13.9) 70.05  (.49)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 3 participants 10 participants
Female
3
  42.9%
1
  33.3%
4
  40.0%
Male
4
  57.1%
2
  66.7%
6
  60.0%
Education  
Mean (Standard Deviation)
Unit of measure:  Years of Education
Number Analyzed 7 participants 3 participants 10 participants
12.3  (4.6) 18.0  (2.0) 15.15  (4.0)
1.Primary Outcome
Title Safety Assessments: Number of Participants With Adverse Events
Hide Description vital signs, physical exam, Symptom Checklist, complete blood count, serum chemistries, urinalysis, and electrocardiogram
Time Frame Safety Labs, Physical Exams: 6 times over 7 weeks. Adverse Events assessed 21 times over the course of 7 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIC5-15 Placebo
Hide Arm/Group Description:

Subjects with Alzheimer's Disease

NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects

Subjects with Alzheimer's Disease

Placebo: placebo comparator

Overall Number of Participants Analyzed 7 3
Measure Type: Count of Participants
Unit of Measure: Participants
07
 100.0%
02
  66.7%
2.Secondary Outcome
Title Changes From Baseline in Clinical Measures of Cognition at Terminal Visit
Hide Description Mini-Mental Status Exam (MMSE) 0(worst)-30(best); ADAS-cog 0 (best cognitive performance across multiple domains) - 70(worst); Activities of Daily Living (ADCS-ADL) 0(least capable of function in daily and instrumental activities)-54(best)
Time Frame baseline and six weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIC5-15 Placebo
Hide Arm/Group Description:

Subjects with Alzheimer's Disease

NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects

Subjects with Alzheimer's Disease

Placebo: placebo comparator

Overall Number of Participants Analyzed 7 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
MMSE .8  (1.02) -5.3  (6.4)
ADAS-cog 2  (2.1) 5.3  (3.2)
ADCS-ADLs 1  (2.8) 1.7  (7.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NIC5-15 Placebo
Hide Arm/Group Description

Subjects with Alzheimer's Disease

NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects

Subjects with Alzheimer's Disease

Placebo: placebo comparator

All-Cause Mortality
NIC5-15 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NIC5-15 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
NIC5-15 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/7 (100.00%)      2/3 (66.67%)    
Blood and lymphatic system disorders     
Hyperglycemic Lab Value   2/7 (28.57%)  2 0/3 (0.00%)  0
Hypoglycemic Lab Value   1/7 (14.29%)  1 0/3 (0.00%)  0
Low Hemocrit Lab Value  [1]  1/7 (14.29%)  1 0/3 (0.00%)  0
Gastrointestinal disorders     
Diarrhea   1/7 (14.29%)  1 0/3 (0.00%)  0
Vomitting   1/7 (14.29%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Joint Pain   1/7 (14.29%)  1 0/3 (0.00%)  0
Nervous system disorders     
Dizziness   0/7 (0.00%)  0 1/3 (33.33%)  1
Syncope   1/7 (14.29%)  1 0/3 (0.00%)  0
Psychiatric disorders     
Insomnia   1/7 (14.29%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Scratchy Throat   1/7 (14.29%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Discomfort and Pain at Needle Injection Site   1/7 (14.29%)  1 0/3 (0.00%)  0
Bleeding from Scratch on Arm   1/7 (14.29%)  1 0/3 (0.00%)  0
Social circumstances     
Fall   1/7 (14.29%)  1 1/3 (33.33%)  1
Indicates events were collected by systematic assessment
[1]
Patient had chronic anemia
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Hillel Grossman
Organization: James J Peters VA Medical Center
Phone: 718-584-9000 ext 5752
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00470418     History of Changes
Other Study ID Numbers: MHBB-009-06S
R21AT003302-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 4, 2007
First Posted: May 7, 2007
Results First Submitted: January 16, 2014
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017