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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470418
First Posted: May 7, 2007
Last Update Posted: January 9, 2017
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.
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Humanetics Corporation
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: January 16, 2014  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
5 subjects did not meet entry criteria and were not baselined

Reporting Groups
  Description
NIC5-15

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: placebo comparator identical in pill size, appearance and number

Subjects with Alzheimer's Disease


Participant Flow:   Overall Study
    NIC5-15   Placebo
STARTED   7   3 
COMPLETED   6   3 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
NIC5-15

Subjects with Alzheimer's Disease

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

Placebo

Subjects with Alzheimer's Disease

Placebo: placebo comparator

Total Total of all reporting groups

Baseline Measures
   NIC5-15   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   3   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.4  (12.5)   69.7  (13.9)   70.05  (.49) 
Gender 
[Units: Participants]
Count of Participants
     
Female      3  42.9%      1  33.3%      4  40.0% 
Male      4  57.1%      2  66.7%      6  60.0% 
Education 
[Units: Years of Education]
Mean (Standard Deviation)
 12.3  (4.6)   18.0  (2.0)   15.15  (4.0) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Changes From Baseline in Clinical Measures of Cognition at Terminal Visit   [ Time Frame: baseline and six weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: hillel.grossman2@va.gov



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