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

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: NCT01383161
Recruitment Status : Completed
First Posted : June 28, 2011
Results First Posted : March 19, 2018
Last Update Posted : October 17, 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
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Curcumin Placebo
Hide Arm/Group Description

Theracurmin (180mg/day)

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

Sugar Pill

Placebo: Six capsules per day for 18 months.

Period Title: Overall Study
Started 25 21
Completed 20 17
Not Completed 5 4
Reason Not Completed
Adverse Event             5             1
Withdrawal by Subject             0             2
Lack of Efficacy             0             1
Arm/Group Title Curcumin Placebo Total
Hide Arm/Group Description

Theracurmin (180mg/day)

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

Sugar Pill

Placebo: Six capsules per day for 18 months.

Total of all reporting groups
Overall Number of Baseline Participants 25 21 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 21 participants 46 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]
Measure Analysis Population Description: Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 21 participants 46 participants
64.5  (8.6) 62.5  (9.0) 63.6  (8.8)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 21 participants 46 participants
Female
16
  64.0%
11
  52.4%
27
  58.7%
Male
9
  36.0%
10
  47.6%
19
  41.3%
[1]
Measure Analysis Population Description: 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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 21 participants 46 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]
Measure Analysis Population Description: 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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 21 participants 46 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]
Measure Analysis Population Description: Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 21 participants 46 participants
25
 100.0%
21
 100.0%
46
 100.0%
1.Primary Outcome
Title Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Recall
Hide Description The Brief Visual Memory Test-Revised (BVMT-R) provides a measure of visual memory. In three learning trials, the respondent views 6 geometric figures for 10 seconds and is asked to draw as many of the figures as possible from memory in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Recall measures standard scoring of designs for accuracy and correct placement across the three trials. Scores across the three trials are summed and range from 0 to 36, with higher scores indicating better learning. There are 6 equivalent alternate forms.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Placebo
Hide Arm/Group Description:

Theracurmin (180mg/day)

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

Sugar Pill

Placebo: Six capsules per day for 18 months.

Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Cognitive Score 19.2  (6.9) 20.3  (6.0)
18-Month Cognitive Score 22.4  (6.4) 22.5  (7.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method mixed-effects general linear model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Delay
Hide Description The Brief Visual Memory Test-Revised (BVMT-R) provides a measure of visual memory. In three learning trials, the respondent views 6 geometric figures for 10 seconds and is asked to draw as many of the figures as possible from memory in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Delayed recall measures standard scoring of designs for accuracy and correct placement after delay period. Scores range from 0 to 12 and reflect recent, long-term learning, with higher scores indicating better learning. There are 6 equivalent alternate forms.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Placebo
Hide Arm/Group Description:

Theracurmin (180mg/day)

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

Sugar Pill

Placebo: Six capsules per day for 18 months.

Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Cognitive Score 7.3  (2.7) 8.3  (2.5)
18-Month Cognitive Score 8.5  (2.1) 8.5  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method mixed-effects general linear model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .006
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline on Buschke Selective Reminding Task, Consistent Long-Term Retrieval
Hide Description Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Consistent Long-Term Retrieval score is the number of words that the subject recalls without receiving prompts and indicates how well the subject consolidates the new information during the learning phase (encoding). Scores indicate the sum of consistent long-term word retrieval across the 12 trials and range from 0 to 144, with higher scores indicating better learning.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Placebo
Hide Arm/Group Description:

Theracurmin (180mg/day)

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

Sugar Pill

Placebo: Six capsules per day for 18 months.

Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Cognitive Score 72.3  (31.6) 73.7  (31.8)
18-Month Cognitive Score 92.6  (30.9) 75.6  (36.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method mixed-effects general linear model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline on Buschke Selective Reminding Task, Total Score
Hide Description Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Total Recall score is the sum of words recalled over the 12 trials, which reflects immediate recall (short-term memory) for new information. Scores range from 0 to 144, with higher scores indicating better learning.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Placebo
Hide Arm/Group Description:

Theracurmin (180mg/day)

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

Sugar Pill

Placebo: Six capsules per day for 18 months.

Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Cognitive Score 113.7  (13.9) 111.3  (15.6)
18-Month Cognitive Score 121.7  (13.2) 112.9  (18.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method mixed-effects general linear model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to 18 Months on Trail Making Test, Part A
Hide Description Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part A is a timed test that consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in circles. The respondent is asked to draw a circle from number one, and so on, in correct numerical order, until they reach number 25. Results are reported as the number of seconds required to complete the task. Respondents were allotted as much time as necessary to complete the task. Higher scores indicate greater impairment.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Placebo
Hide Arm/Group Description:

Theracurmin (180mg/day)

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

Sugar Pill

Placebo: Six capsules per day for 18 months.

Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: seconds
Baseline Cognitive Score 32.6  (9.3) 30.5  (8.3)
18-Month Cognitive Score 24.9  (5.3) 28.4  (10.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method mixed-effects general linear model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to 18 Months on Beck Depression Inventory (BDI)
Hide Description Beck Depression Inventory is a self-reported questionnaire consisting of 21 items that assess for core depressive symptoms, including sadness, sleep, suicidality, and anhedonia. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (no depressive symptoms) to 84 (extreme depression), with higher scores indicating more significant depression.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Placebo
Hide Arm/Group Description:

Theracurmin (180mg/day)

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

Sugar Pill

Placebo: Six capsules per day for 18 months.

Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Mood Score 4.6  (4.5) 4.4  (3.4)
18-Month Mood Score 2.7  (2.5) 4.0  (5.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Curcumin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method mixed-effects general linear model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Curcumin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 18 months
Adverse Event Reporting Description A review of possible adverse events was performed with participants every 3 months
 
Arm/Group Title Curcumin Placebo
Hide Arm/Group Description

Theracurmin (180mg/day)

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

Sugar Pill

Placebo: Six capsules per day for 18 months.

All-Cause Mortality
Curcumin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Curcumin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Curcumin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/25 (20.00%)      1/21 (4.76%)    
Gastrointestinal disorders     
Gastrointestinal Complaints  [1]  1/25 (4.00%)  1 0/21 (0.00%)  0
Gastrointestinal Complaints  [2]  3/25 (12.00%)  3 1/21 (4.76%)  1
Nervous system disorders     
Abnormal MRI * [3]  1/25 (4.00%)  1 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Participant reported single adverse event of heartburn and bloating.
[2]
General gastrointestinal complaints reported.
*
Indicates events were collected by non-systematic assessment
[3]
Abnormal MRI unrelated to study intervention diagnosed at baseline scan.
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
Layout table for Results Point of Contact information
Name/Title: Gary Small, MD
Organization: University of California, Los Angeles
Phone: 310-825-0291
EMail: gsmall@mednet.ucla.edu
Publications:
[No authors listed] Consensus report of the Working Group on:
Layout table for additonal information
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: October 17, 2018