Trial Outcomes & Findings for 18-Month Study of Memory Effects of Curcumin (NCT NCT01383161)

NCT ID: NCT01383161

Last Updated: 2020-03-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 46 participants
• Primary outcome timeframe: Baseline and 18 Months
• Results posted on: 2020-03-03

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	25	21
Overall Study COMPLETED	20	17
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	5	1
Overall Study Withdrawal by Subject	0	2
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.

Baseline characteristics by cohort

Measure	Curcumin n=25 Participants Theracurmin (180mg/day) Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months.	Placebo n=21 Participants Sugar Pill Placebo: Six capsules per day for 18 months.	Total n=46 Participants Total of all reporting groups
Sex: Female, Male Female	16 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	11 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	27 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Age, Categorical <=18 years	0 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Age, Categorical Between 18 and 65 years	15 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	14 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	29 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Age, Categorical >=65 years	10 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	7 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	17 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Age, Continuous	64.5 years STANDARD_DEVIATION 8.6 • n=93 Participants	62.5 years STANDARD_DEVIATION 9.0 • n=4 Participants	63.6 years STANDARD_DEVIATION 8.8 • n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	10 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	19 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	1 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	21 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	45 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Race (NIH/OMB) Asian	1 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	4 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	5 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	1 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	2 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Race (NIH/OMB) White	23 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	16 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	39 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Race (NIH/OMB) More than one race	0 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=4 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.	0 Participants n=27 Participants • Baseline numbers include all participants who completed baseline measures. Only participants for whom comparison data was obtained were included in analyses.
Region of Enrollment United States	25 Participants n=93 Participants	21 Participants n=4 Participants	46 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 18 Months

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.

Outcome measures

Measure	Curcumin n=20 Participants Theracurmin (180mg/day) Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months.	Placebo n=17 Participants Sugar Pill Placebo: Six capsules per day for 18 months.
Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Recall Baseline Cognitive Score	19.2 units on a scale Standard Deviation 6.9	20.3 units on a scale Standard Deviation 6.0
Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Recall 18-Month Cognitive Score	22.4 units on a scale Standard Deviation 6.4	22.5 units on a scale Standard Deviation 7.8

PRIMARY outcome

Timeframe: Baseline and 18 Months

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.

Outcome measures

Measure	Curcumin n=20 Participants Theracurmin (180mg/day) Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months.	Placebo n=17 Participants Sugar Pill Placebo: Six capsules per day for 18 months.
Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Delay Baseline Cognitive Score	7.3 units on a scale Standard Deviation 2.7	8.3 units on a scale Standard Deviation 2.5
Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Delay 18-Month Cognitive Score	8.5 units on a scale Standard Deviation 2.1	8.5 units on a scale Standard Deviation 2.8

PRIMARY outcome

Timeframe: Baseline and 18 Months

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.

Outcome measures

Measure	Curcumin n=20 Participants Theracurmin (180mg/day) Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months.	Placebo n=17 Participants Sugar Pill Placebo: Six capsules per day for 18 months.
Change From Baseline on Buschke Selective Reminding Task, Consistent Long-Term Retrieval Baseline Cognitive Score	72.3 units on a scale Standard Deviation 31.6	73.7 units on a scale Standard Deviation 31.8
Change From Baseline on Buschke Selective Reminding Task, Consistent Long-Term Retrieval 18-Month Cognitive Score	92.6 units on a scale Standard Deviation 30.9	75.6 units on a scale Standard Deviation 36.4

PRIMARY outcome

Timeframe: Baseline and 18 Months

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.

Outcome measures

Measure	Curcumin n=20 Participants Theracurmin (180mg/day) Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months.	Placebo n=17 Participants Sugar Pill Placebo: Six capsules per day for 18 months.
Change From Baseline on Buschke Selective Reminding Task, Total Score Baseline Cognitive Score	113.7 units on a scale Standard Deviation 13.9	111.3 units on a scale Standard Deviation 15.6
Change From Baseline on Buschke Selective Reminding Task, Total Score 18-Month Cognitive Score	121.7 units on a scale Standard Deviation 13.2	112.9 units on a scale Standard Deviation 18.4

SECONDARY outcome

Timeframe: Baseline and 18 Months

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.

Outcome measures

Measure	Curcumin n=20 Participants Theracurmin (180mg/day) Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months.	Placebo n=17 Participants Sugar Pill Placebo: Six capsules per day for 18 months.
Change From Baseline to 18 Months on Trail Making Test, Part A Baseline Cognitive Score	32.6 seconds Standard Deviation 9.3	30.5 seconds Standard Deviation 8.3
Change From Baseline to 18 Months on Trail Making Test, Part A 18-Month Cognitive Score	24.9 seconds Standard Deviation 5.3	28.4 seconds Standard Deviation 10.8

SECONDARY outcome

Timeframe: Baseline and 18 Months

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.

Outcome measures

Measure	Curcumin n=20 Participants Theracurmin (180mg/day) Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months.	Placebo n=17 Participants Sugar Pill Placebo: Six capsules per day for 18 months.
Change From Baseline to 18 Months on Beck Depression Inventory (BDI) Baseline Mood Score	4.6 units on a scale Standard Deviation 4.5	4.4 units on a scale Standard Deviation 3.4
Change From Baseline to 18 Months on Beck Depression Inventory (BDI) 18-Month Mood Score	2.7 units on a scale Standard Deviation 2.5	4.0 units on a scale Standard Deviation 5.0

Adverse Events

Curcumin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Curcumin n=25 participants at risk Theracurmin (180mg/day) Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months.	Placebo n=21 participants at risk Sugar Pill Placebo: Six capsules per day for 18 months.
Gastrointestinal disorders Gastrointestinal Complaints	12.0% 3/25 • Number of events 3 • 18 months A review of possible adverse events was performed with participants every 3 months	4.8% 1/21 • Number of events 1 • 18 months A review of possible adverse events was performed with participants every 3 months
Nervous system disorders Abnormal MRI	4.0% 1/25 • Number of events 1 • 18 months A review of possible adverse events was performed with participants every 3 months	0.00% 0/21 • 18 months A review of possible adverse events was performed with participants every 3 months

Additional Information

Gary Small, MD

University of California, Los Angeles

Phone: 310-825-0291

Email: gsmall@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place