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Early Intervention in Mild Cognitive Impairment (MCI) With Curcumin + Bioperine

This study has been terminated.
(For various reasons.)
Sponsor:
Information provided by (Responsible Party):
James C. Patterson, II, MD. Ph, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier:
NCT00595582
First received: January 4, 2008
Last updated: May 25, 2012
Last verified: May 2012
Results First Received: October 11, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Mild Cognitive Impairment
Intervention: Dietary Supplement: curcumin + bioperine

  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
Subjects were initially recruited for an MCI study which was IRB approved 9-29-03 and subjects were recruited from a medical clinic and advertising.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Curcumin + Bioperine Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.

Participant Flow:   Overall Study
    Curcumin + Bioperine  
STARTED     10  
COMPLETED     0  
NOT COMPLETED     10  
Pilot study that PI terminated                 2  
Lost to Follow-up                 1  
Adverse Event                 2  
Physician Decision                 5  



  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
Curcumin + Bioperine Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.

Baseline Measures
    Curcumin + Bioperine  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     10  
Age  
[units: years]
Mean ± Standard Deviation
  77.6  ± 5.83476  
Gender  
[units: participants]
 
Female     7.0  
Male     3.0  
Region of Enrollment  
[units: participants]
 
United States     10.0  



  Outcome Measures

1.  Primary:   Neuropsychological Scores in Patients With MCI or Mild AD.   [ Time Frame: within the next three years ]


  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
2 patients withdrew due to Dyspepsia (intolerance to supplement).


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. James Patterson/Professor
Organization: LSU Health Sciences Center, Shreveport LA
phone: 318-813-2070
e-mail: jpatte@lsuhsc.edu


No publications provided


Responsible Party: James C. Patterson, II, MD. Ph, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT00595582     History of Changes
Other Study ID Numbers: LSU#H05-168, LSU#H05-168
Study First Received: January 4, 2008
Results First Received: October 11, 2011
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board