Trial Outcomes & Findings for MemoryXL Effects on Mild Cognitive Impairment Patients (NCT NCT00903695)

Results Overview

Dementia Rating Scale (DRS) is a cognitive test with 5 domains; raw scores can be converted to percentiles for age/education levels, so individuals can be compared. Higher scores mean more competence (0-36 points converted to percentiles so different ages can be compared). Total raw scores for the 5 domains were computed so that Mean and SD of differences between first and last assessments for all subjects, by study arms (nutriceutical = XL and placebo = PL) are reported here.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2012-01-26

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	8	2
Overall Study COMPLETED	6	2
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study medical exclusion after 1st testing	1	0
Overall Study lung cancer	1	0

Baseline Characteristics

MemoryXL Effects on Mild Cognitive Impairment Patients

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: All participants who completed 12-month study were included in the ANOVA analysis of the differences in scores of tests between baseline and end assessments.

Dementia Rating Scale (DRS) is a cognitive test with 5 domains; raw scores can be converted to percentiles for age/education levels, so individuals can be compared. Higher scores mean more competence (0-36 points converted to percentiles so different ages can be compared). Total raw scores for the 5 domains were computed so that Mean and SD of differences between first and last assessments for all subjects, by study arms (nutriceutical = XL and placebo = PL) are reported here.

Outcome measures

Outcome measures
Measure	Nutriceutical Arm n=6 Participants Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.	Placebo Arm n=2 Participants Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group	-1.0 units on a scale Standard Deviation 3.0	-2.5 units on a scale Standard Deviation 5.3

PRIMARY outcome

Timeframe: baseline before intervention to 12 months of intervention

Population: All subjects who completed the 12-month study were included (placebo and nutriceutical arms/groups).

CDR is a rating scale for 8 aspects of behavior with 0-3 points allowed; higher scores indicate more pathology. Total minimum and maximum scores are 0 and 36 respectively.Clinician rates the patient's behavior and competence with input from family members who live with the patient. ANOVA of differences between baseline and end scores of the CDR scale are reported here, by the study arm/group.