Trial Outcomes & Findings for Early Intervention in Mild Cognitive Impairment (MCI) With Curcumin + Bioperine (NCT NCT00595582)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

within the next three years

Results posted on

2012-05-28

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.

Participant milestones
Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	10

Reasons for withdrawal
Measure	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.
Overall Study Pilot study that PI terminated	2
Overall Study Lost to Follow-up	1
Overall Study Adverse Event	2
Overall Study Physician Decision	5

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

Baseline characteristics by cohort
Measure	Curcumin + Bioperine n=10 Participants 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.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	10 Participants n=99 Participants
Age Continuous	77.6 years STANDARD_DEVIATION 5.83476 • n=99 Participants
Sex: Female, Male Female	7.0 Participants n=99 Participants
Sex: Female, Male Male	3.0 Participants n=99 Participants
Region of Enrollment United States	10.0 participants n=99 Participants

Timeframe: within the next three years

Population: No data were collected as this study was terminated.

Outcome data not reported

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Curcumin + Bioperine n=10 participants at risk 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.
Gastrointestinal disorders dyspepsia	20.0% 2/10 • 3 years

LSU Health Sciences Center, Shreveport LA

Phone: 318-813-2070