MemoryXL Effects on Mild Cognitive Impairment Patients

This study has been terminated.

(Risk/benefit ratio did not indicate further study would be useful, or fair to future subjects.)

Sponsor:

Information provided by (Responsible Party):

University of Oklahoma

ClinicalTrials.gov Identifier:

NCT00903695

First received: May 14, 2009

Last updated: January 25, 2012

Last verified: January 2012

History of Changes

Results First Received: July 26, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Prevention
Condition:	Mild Cognitive Impairment
Interventions:	Drug: Memory XL Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients diagnosed with Mild Cognitive Impairment (MCI) in VA and OU campus clinics were given opportunity to participate in the trial, if they met inclusion/exclusion criteria.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Over 1.5 yrs, only 19 of 533 memory clinic patients were diagnosed with Mild Cognitive Impairment and who met inclusion/exclusion criteria. Most of the MCI patients had serious medical problems that affected cognition. Ten subjects agreed to be in this study.

Reporting Groups

Description

Nutriceutical (MemoryXL) Effects on Cognition & Behavior

Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.

Placebo Effects on Cognition/Behavior

Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.

Participant Flow: Overall Study

	Nutriceutical (MemoryXL) Effects on Cognition & Behavior	Placebo Effects on Cognition/Behavior
STARTED	8	2
COMPLETED	6	2
NOT COMPLETED	2	0
medical exclusion after 1st testing	1	0
lung cancer	1	0

Baseline Characteristics

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Reporting Groups

	Description
Nutriceutical (MemoryXL) Effects on Cognition & Behavior	Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
Placebo Effects on Cognition/Behavior	Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
Total	Total of all reporting groups

Baseline Measures

	Nutriceutical (MemoryXL) Effects on Cognition & Behavior	Placebo Effects on Cognition/Behavior	Total
Number of Participants [units: participants]	8	2	10
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	1	0	1
>=65 years	7	2	9
Gender [units: participants]
Female	0	0	0
Male	8	2	10
Region of Enrollment [units: participants]
United States	8	2	10
Dementia Rating Scale ^[1] [units: total raw score points for 5 domains] Mean ± Standard Deviation	130 ± 2.3	140 ± 4.7	132 ± 7.5
MiniMental State Exam (MMSE) ^[2] [units: total 1st MMSE score parameters] Mean ± Standard Deviation	27.5 ± 0.8	28.5 ± 1.5	27.7 ± 2.1
Neuropsychiatric Inventory NPI) ^[3] [units: total raw scores by group] Mean ± Standard Deviation	3.6 ± 1.3	3.0 ± 2.6	3.5 ± 3.4
Modified Clinical Dementia Rating scale (CDR) ^[4] [units: total raw scores by study group] Mean ± Standard Deviation	5.6 ± 1.4	6.5 ± 2.8	5.8 ± 3.8
Activities of Daily Living (ADL) ^[5] [units: total initial raw scores by group] Mean ± Standard Deviation	6.3 ± 0.4	8.0 ± 0.7	6.6 ± 1.2
Instrumental Activities of Daily Living (IADL) ^[6] [units: total initial scores by study group] Mean ± Standard Deviation	14.2 ± 1.8	13.0 ± 3.7	14.0 ± 4.9
Clock Drawing Test ^[7] [units: initial total raw score by group] Mean ± Standard Deviation	6.7 ± 0.3	7.0 ± 0.7	6.8 ± 0.9

[1]	Dementia Rating Scale (DRS) = cognitive test with 5 domains; raw scores can be converted to percentiles for age/education levels. Higher scores mean more competence (range = 0 to 180 points).
[2]	MiniMental State Exam (MMSE) is a cognitive screening device with possible 30 points; higher scores mean more competence, and scores can range from 0-30 points.
[3]	Neuropsychiatric Inventory (NPI) behavior rating scale includes 12 domains; higher numbers mean more psychiatric pathology (0 to 36 points).
[4]	Modified CDR is a behavior rating scale of 8 domains, with 5 incremental scores for each domain (0, 0.5, 1, 2, 3). Total raw score of 0 means patient is healthy; raw score of 1 to <8 points from the 8 domains earns subject a CDR scale score of 0.5 (Mild Cognitive Impairment, no dementia). Total scaled score of 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia.
[5]	ADL is a behavior rating scale with 6 domains of self-care (feeding, toileting, etc.), with 3 incremental scores (1, 2, 3) in which higher scores mean more pathology (total scores of 6 to 18 points).
[6]	IADL is a behavior rating scale with 9 domains, and 3 incremental scores ( 1, 2, 3). Total scores can range from 9 to 27, with higher scores indicating more pathology.
[7]	Clock Drawing Test is a cognitive screening instrument in which subjects are asked to draw a traditional clock and place the hands at a specified time. Scoring in this version used 8 indicators of accuracy and skill, with higher scores showing more competence (0-8 pts possible).

Outcome Measures

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1. Primary:

Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group [ Time Frame: Baseline and 12 months ]

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2. Primary:

Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group [ Time Frame: baseline before intervention to 12 months of intervention ]

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3. Primary:

Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group [ Time Frame: baseline to 12 months ]

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4. Primary:

Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group [ Time Frame: baseline to 12 months ]

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5. Primary:

Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group [ Time Frame: baseline to 12 months ]

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6. Primary:

Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group [ Time Frame: baseline to 12 months ]

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7. Primary:

Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group [ Time Frame: baseline to 12 months ]

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8. Secondary:

Number of Subjects Who Converted to Early Alzheimer's (Dementia). [ Time Frame: 12 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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
Benefits of study did not appear to outweigh subject inconvenience, so study was stopped prematurely. Also, very few 'healthy' MCI subjects were recruited from the clinic population; vast majority of MCI patients had exclusionary medical problems.

Results Point of Contact:

Name/Title: Marilee Monnot, PhD
Organization: UOklahoma Health Sciences Center
phone: 405-456-5773 ext 5773
e-mail: marilee-monnot@ouhsc.edu

No publications provided

Responsible Party:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00903695 History of Changes
Other Study ID Numbers:	14594
Study First Received:	May 14, 2009
Results First Received:	July 26, 2011
Last Updated:	January 25, 2012
Health Authority:	United States: Food and Drug Administration

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