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18-Month Study of Memory Effects of Curcumin (Curcumin)

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ClinicalTrials.gov Identifier: NCT01383161
Recruitment Status : Completed
First Posted : June 28, 2011
Results First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gary Small, MD, University of California, Los Angeles

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Age-associated Cognitive Impairment
Mild Cognitive Impairment (MCI)
Interventions: Drug: Curcumin
Other: Placebo

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Curcumin

Theracurmin (180mg/day)

Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months.

Placebo

Sugar Pill

Placebo: Six capsules per day for 18 months.


Participant Flow:   Overall Study
    Curcumin   Placebo
STARTED   25   21 
COMPLETED   20   17 
NOT COMPLETED   5   4 
Adverse Event                5                1 
Withdrawal by Subject                0                2 
Lack of Efficacy                0                1 



  Baseline Characteristics

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

Theracurmin (180mg/day)

Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months.

Placebo

Sugar Pill

Placebo: Six capsules per day for 18 months.

Total Total of all reporting groups

Baseline Measures
   Curcumin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   21   46 
Age [1] 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      15  60.0%      14  66.7%      29  63.0% 
>=65 years      10  40.0%      7  33.3%      17  37.0% 
[1] Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Age 
[Units: Years]
Mean (Standard Deviation)
 64.5  (8.6)   62.5  (9.0)   63.6  (8.8) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Female      16  64.0%      11  52.4%      27  58.7% 
Male      9  36.0%      10  47.6%      19  41.3% 
[1] Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   4.0%      0   0.0%      1   2.2% 
Not Hispanic or Latino      24  96.0%      21 100.0%      45  97.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
[1] Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   4.0%      4  19.0%      5  10.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   4.0%      1   4.8%      2   4.3% 
White      23  92.0%      16  76.2%      39  84.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
[1] Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   25   21   46 


  Outcome Measures

1.  Primary:   Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Recall   [ Time Frame: Baseline and 18 Months ]

2.  Primary:   Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Delay   [ Time Frame: Baseline and 18 Months ]

3.  Primary:   Change From Baseline on Buschke Selective Reminding Task, Consistent Long-Term Retrieval   [ Time Frame: Baseline and 18 Months ]

4.  Primary:   Change From Baseline on Buschke Selective Reminding Task, Total Score   [ Time Frame: Baseline and 18 Months ]

5.  Secondary:   Change From Baseline to 18 Months on Trail Making Test, Part A   [ Time Frame: Baseline and 18 Months ]

6.  Secondary:   Change From Baseline to 18 Months on Beck Depression Inventory (BDI)   [ Time Frame: Baseline and 18 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Gary Small, MD
Organization: University of California, Los Angeles
phone: 310-825-0291
e-mail: gsmall@mednet.ucla.edu


Publications:
[No authors listed] Consensus report of the Working Group on:


Responsible Party: Gary Small, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01383161     History of Changes
Other Study ID Numbers: 11-001740
IND 112714 ( Other Identifier: FDA )
First Submitted: June 22, 2011
First Posted: June 28, 2011
Results First Submitted: January 4, 2018
Results First Posted: March 19, 2018
Last Update Posted: March 19, 2018