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

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

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 ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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

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