Mild Cognitive ImpairmentPhase 2MemoryXLNCT00903695

MemoryXL Effects on Mild Cognitive Impairment Patients

A Phase 2 study testing Memory XL in people with Mild Cognitive Impairment, run by University of Oklahoma at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 55 to 85 years
Conditions the study is for: Mild Cognitive Impairment
What is being tested?: Memory XL
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 2 sitesUnited States
Study dates: Jun 2009to May 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Univ. of Okla. Health Sciences Center & VAMC OKC
Oklahoma City, Oklahoma, 73104
Veterans Affairs Medical Center
Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: Nutriceutical Effects on Cognitive Status in Mild Cognitive Impairment Patients

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.

Read the detailed 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).

Conditions: Mild Cognitive Impairment
Being tested: Memory XL, placebo
Keywords: Memory XL, Mild Cognitive Impairment, cognitive status
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Memory XLDrug
Also called nutriceutical
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
placeboDrug
placebo comparator

Study groups in NCT00903695
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: baseline to 12 months

Secondary outcomes (1)

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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009May 2011

First posted18 May 2009 (estimated)
Study startJun 2009
Primary completionMay 2011
Study completionMay 2011

Why it stopped: Risk/benefit ratio did not indicate further study would be useful, or fair to future subjects.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by University of OklahomaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00903695
Sponsor's protocol ID: 14594
Acronym: MemoryXL
Status last verified: Jan 2012
First submitted: 14 May 2009
Last updated: 26 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mild Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nutriceutical Effects on Cognitive Status in Mild Cognitive Impairment Patients
ClinicalTrials.gov ID: NCT00903695
Acronym / sponsor ID: MemoryXL / 14594
Conditions: Mild Cognitive Impairment
Keywords: Memory XL, Mild Cognitive Impairment, cognitive status
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Risk/benefit ratio did not indicate further study would be useful, or fair to future subjects.
Enrolment: 10 participants (actual)
Lead sponsor: University of OklahomaUniversity, hospital or other
Study start: Jun 2009
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 18 May 2009 (estimated)
Results: Posted 26 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Memory XL	Experimental	Drug: Memory XLSubjects 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.
placebo	Placebo comparator	Drug: placeboSubjects 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.

Who may qualify

Ages: 55 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Memory XLAlso: nutriceuticalAn 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	Drug	Memory XL
placeboplacebo comparator	Drug	placebo

Primary outcome

Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group
Time frame: Baseline and 12 months
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.
Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group
Time frame: baseline before intervention to 12 months of intervention
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.
Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group
Time frame: baseline to 12 months
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.
Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group
Time frame: baseline to 12 months
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.
Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group
Time frame: baseline to 12 months
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.
Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group
Time frame: baseline to 12 months
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.
Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group
Time frame: baseline to 12 months
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).

1 secondary outcome

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

Results and safety

Results posted to the registry on 26 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nutriceutical (MemoryXL) Effects on Cognition & Behavior	8	6
Placebo Effects on Cognition/Behavior	2	2

Primary outcome: Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group

Time frame: Baseline and 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Nutriceutical (MemoryXL) Effects on Cognition & Behavior n = 6	Placebo Effects on Cognition/Behavior n = 2
Value	-1.0 (3.0)	-2.5 (5.3)

Nutriceutical (MemoryXL) Effects on Cognition & Behavior vs Placebo Effects on Cognition/Behavior: p = 0.8133, ANOVA

Population analysed: 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.

Primary outcome: Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group

Time frame: baseline before intervention to 12 months of intervention. Mean (Standard Error). Unit: units on a scale

Measure	Nutriceutical Arm n = 6	Placebo Arm n = 2
Value	-1.7 (1.6)	2.0 (2.9)

Nutriceutical Arm vs Placebo Arm: p = 0.31, ANOVA

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

Primary outcome: Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group

Time frame: baseline to 12 months. Mean (Standard Error). Unit: units on a scale

Measure	Nutriceutical Arm n = 6	Placebo Arm n = 2
Value	0.5 (0.6)	-1.0 (1.1)

Nutriceutical Arm vs Placebo Arm: p = 0.27, ANOVA

Population analysed: All subjects who completed the 12-month study were included.

Primary outcome: Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group

Time frame: baseline to 12 months. Mean (Standard Error). Unit: units on a scale

Measure	Nutriceutical Arm n = 6	Placebo Arm n = 2
Value	-0.33 (0.5)	1.0 (0.9)

Nutriceutical Arm vs Placebo Arm: p = 0.24, ANOVA

Population analysed: All subjects who completed the 12-month study were included.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12-month study (double-blind) of Mild Cognitive Impairment patients recruited from VAMC Neurosciences memory loss clinic.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nutriceutical (MemoryXL) Effects on Cognition & Behavior	0 of 8 (0%)	0 of 8 (0%)	Not reported
Placebo Effects on Cognition/Behavior	0 of 2 (0%)	0 of 2 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundChan, A., Paskavitz, J., Remington, J.R., Rasmussen, S., Shea, T.B. (2009).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marilee Monnot, Ph.D. principal investigator

University of Oklahoma HSC

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Memory XL in people with Mild Cognitive Impairment, run by University of Oklahoma at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group (time frame: Baseline and 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00903695, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2012.