MemoryXL Effects on Mild Cognitive Impairment Patients

Mild Cognitive Impairment Clinical Trial

— MemoryXL  

Official title:

Nutriceutical Effects on Cognitive Status in Mild Cognitive Impairment Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00903695
• Other study ID #: 14594
• Status: Terminated
• Phase: Phase 2
• First received: May 14, 2009
• Last updated: January 25, 2012
• Start date: June 2009
• Est. completion date: May 2011

Study information

• Verified date: January 2012
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A vitamin nutriceutical, Memory XL, has been shown to provide maintenance of cognitive status in mild, moderate, and severe Alzheimer's disease patients (2 publications by T. Shea). Because this nutriceutical is now patented by the Univ. of Mass., other trials at that institution may be considered a conflict of interest. Therefore, a study of its effects on Mild Cognitive Impairment (MCI) patients will be conducted by PI who is not affiliated with Univ. of Mass. or with Dr. Shea. The study hypothesis is: Memory XL will maintain or improve the cognitive and behavioral status of patients diagnosed with MCI during the year of participation in the study; normally, 10-25% of MCI patients convert to mild Alzheimer's dementia each year.

Description:

This IRB-approved study is a randomized double blind study of patients diagnosed with Mild Cognitive Impairment (MCI) in the Center for Alzheimer's and Neurodegenerative Disorders (CANDO) at VAMC in Oklahoma City. Dr. Shea provided the pills (nutriceutical and placebos) from the same batches he used in former studies of Alzheimer's disease patients (produced by Nutricap Labs, Farmingdale, NY). Pills were dispensed by the OKC VAMC research pharmacist, using a random numbering system. The PI completed five cognitive testing sessions, lasting 1 to 1.5 hours, for each subject during the 12 months of participation in the study. Subject's spouse or family member completed 4 questionnaires about the subject's behavioral changes, and kept daily records of the times each day when the subject ingested the study pill assigned by the pharmacist. All subjects are patients in the VAMC memory loss clinic (CANDO) who are monitored by their neurologists (2 co-investigators in this study).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• MCI patients diagnosed at the VAMC Center for Alzheimers and Neurodegenerative Disorder (CANDO).

• Clinical Dementia Rating (CDR) score of 0.5.

• fluent in English.

• able to ambulate to the outpatient clinic and research laboratory

• have sight and hearing levels sufficient to complete neuropsychological testing.

• free from bipolar disorder and terminal illnesses such as cancer.

• must live with a spouse or adult relative who will record nutriceutical ingestion daily.

• subjects will be consecutively diagnosed patients from all ethnic groups.

Exclusion Criteria:

• patients from protected categories such as prisoners and pregnant women.

• any MCI subject who develops a life-threatening disease such as terminal cancer, stroke, brain trauma, debilitating heart attack, etc.

• indication of inability to make decisions regarding study participation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Drug:
• Memory XL
An over-the-counter vitamin nutriceutical patented by Univ. of Mass. that contains folic acid 400 mg, Vit. B12 6 ug, alpha-tocopherol 30 IU, S-adenosyl methionine (SAM) 400 mg, N-acetyl cysteine (NAC) 600 mg, & acetyl-L-carnitine (ALCAR) 500 mg; 2 pills per day for 12 months
• placebo
placebo comparator

Locations

Country	Name	City	State
United States	Univ. of Okla. Health Sciences Center & VAMC OKC	Oklahoma City	Oklahoma
United States	Veterans Affairs Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chan, A., Paskavitz, J., Remington, J.R., Rasmussen, S., Shea, T.B. (2009).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group	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.	Baseline and 12 months	No
Primary	Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group	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.	baseline before intervention to 12 months of intervention	No
Primary	Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group	Clock Drawing Test is a cognitive screening instrument in which subjects are to draw a clock and set a specified time. Various scoring methods can be employed using 4 to 15 points, with more points showing more competence. This study used the 8-point scoring method, so that 0-8 points could be assigned during each of the baseline and 4 assessment periods during the 12-month study. ANOVA of the differences between baseline and end scores, by study arm/group was completed.	baseline to 12 months	No
Primary	Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group	MiniMental State Exam is a cognitive screening device with possible 30 points in several categories; higher points indicate greater competence. Clinician tests orientation, attention, language, & visuo-spatial construction. Outcome measure is results of an ANOVA of differences between baseline and end/last scores, by study arm/group was completed.	baseline to 12 months	No
Primary	Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group	NPI is a behavior rating scale with 12 categories in which a maximum score of 36 points indicates more pathology than a minimum score of 0. Outcome measure reported here is results of an ANOVA of the differences between baseline and end scores, by study arm/group, to detect any statistically significant difference (nutriceutical vs placebo groups) was completed.	baseline to 12 months	No
Primary	Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group	ADL is a behavior rating scale with 6 domains of self-care (feeding, toileting, etc.) in which a maximum score of 18 indicates less competence than a minimum score of 6 (normal skills). Outcome measure is results of ANOVA of the differences between baseline and last/end scores, by study arm/group, to detect any statistically significant differences.	baseline to 12 months	No
Primary	Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group	IADL is a behavior rating scale using 9 domains of household and community activities, with a total score of 27 points indicating less competence than a normal function score of 9 points. Outcome measure is results of an ANOVA of the differences between baseline and end/last score, by study arm/group, to detect statistically significant differences (nutriceutical vs placebo).	baseline to 12 months	No
Secondary	Number of Subjects Who Converted to Early Alzheimer's (Dementia).	Neurological diagnosis is based on test scores that reach -1.6 SD of mean for age/education, and on radiological tests of brain structure (CT, MRI, PET). Usual cutoff for test score percentile is <0.05 to diagnose dementia.	12 months	No