MemoryXL Effects on Mild Cognitive Impairment Patients

NCT00903695 | Terminated Phase 2 Results DMC

• 1 other identifier: 14594
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

Memory XL; Mild Cognitive Impairment; cognitive status

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Number of Subjects Who Converted to Early Alzheimer's (Dementia).

  12 months

Study Arms (2)

Memory XL

EXPERIMENTAL

Subjects will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D.). Mild Cognitive Impairment (MCI) patients, who met inclusion/exclusion criteria, were assessed initially using 3 cognitive tests and 4 behavioral questionnaires, before they began ingesting pills assigned to them by VAMC Research Pharmacist. Each 3 months thereafter, they returned to lab to be reassessed using same instruments, and to receive the next batch of study pills from the Pharmacist. The last assessment was when the patient had just finished 12 months of pill ingestion.

Drug: Memory XL

placebo

PLACEBO COMPARATOR

Subjects diagnosed with MCI took two placebo pills daily for 12 months; these pills are formulated to look and taste the same as the nutriceutical being studied, Memory XL, so study was double-blind. Procedures for this arm are exactly the same as the MEMORY XL arm. MCI subjects were assessed using 3 cognitive tests and 4 behavioral questionnaires, before they began ingesting the pills assigned to them by the Research Pharmacist at VAMC. Each 3 months thereafter, they returned to lab to be reassessed using the same instruments, and to receive next batch of study pills. Last assessment was when patient had completed 12 months of pill ingestion.

Drug: placebo

Interventions

Memory XL DRUG

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

Also known as: nutriceutical

Memory XL

placebo DRUG

placebo comparator

placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (2)

Univ. of Okla. Health Sciences Center & VAMC OKC

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

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

• Title: Marilee Monnot, PhD
• Organization: UOklahoma Health Sciences Center

marilee-monnot@ouhsc.edu

405-456-5773

Study Officials

• Marilee Monnot, Ph.D.

  University of Oklahoma HSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 18, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 26, 2012
• Results First Posted: January 26, 2012

Record last verified: 2012-01

Locations

US (2)