Mild Cognitive ImpairmentNCT01594541
A Retrospective Analysis of Cerefolin NAC® in Cognitively Impaired Patients
An observational study of Mild Cognitive Impairment, run by Pamlab, Inc. at 1 site in United States.
Trial summary
This retrospective analysis of de-identified data from 700 charts of consecutive patients from this patient population is to investigate the prevalence of hyperhomocysteinemia and associated metabolic abnormalities in this naturalistic grouping of patients with various stages of cognitive loss and diagnosed with… Read more about this study
- Who is it for?
- Ages 55 to 89 years
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medical charts of 700 de-identified elderly patients who underwent evaluation and treatment for cognitive loss.
Who may be able to join
- Individuals between the ages of 55 and 89 years old
- Meeting criteria for Mild Cognitive Impairment or dementia with a minimum MOST score of 5 but not over 23
- Has a minimum of 3 months evaluation
- Able to undergo testing for cognition and complete the GDS
Who cannot join
- Known allergy/intolerance to any ingredient in Cerefolin NAC®
- Substantial impediments to adherence, such as severe dementia without caregiver to administer medication
- Inability to swallow pill-form medication
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
- Hcy score lower than 11
Trial locations and contacts
1 site in 1 country.
United States1 site
Clionsky Neuro Systems, Inc.
Springfield, Massachusetts, 01105
About this study
Official title: Hyperhomocysteinemia in a Mild Cognitive Impairment and Dementia Population: the Effect of Treatment With Cerefolin NAC® in a Naturalistic Community-based Dementia Practice
This retrospective analysis of de-identified data from 700 charts of consecutive patients from this patient population is to investigate the prevalence of hyperhomocysteinemia and associated metabolic abnormalities in this naturalistic grouping of patients with various stages of cognitive loss and diagnosed with various types of dementia.
Read the detailed description
A single-center, retrospective review of the medical charts of 700 de-identified elderly patients who underwent evaluation and treatment for cognitive loss including analysis of:
Laboratory values of interest: homocysteine, methylmalonic acid, CRP, BNP, CO2, TSH, Fe/TIBC, RPR/TPPA/FTA-ABS, and if available, folic acid and B12 levels ordered by primary care providers.
Neuropsychological tests of executive function, memory and affect:
- Wechsler Memory Scale-Revised (WMS-R) or Fourth Edition (WMS-IV)
- Logical Memory -Delayed Recall, Scaled Score
- Visual Reproduction-Delayed Recall, Scaled Score
- Shopping List Test, Delayed Recall
- Trailmaking A and B Tests
- Verbal Absurdities subtest of the Stanford Binet, Form L-M
- Proverbs Test
- Memory Orientation Screening Test
- Folstein Mini-Mental State Exam
- Geriatric Depression Scale, 15 items
Sub-group analysis of MRI volumetrics and PET scans when available. Sequentially pulled from June 1, 2009 to September 2011
- Conditions
- Mild Cognitive Impairment
- Keywords
- hyperhomocysteinemia, dementia, depression, vitamin B12, mild cognitive impairment, alzheimer's
- Medical subject headings
- Cognitive Dysfunction, Hyperhomocysteinemia, Dementia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Treated with CerefolinNAC® | Not described | |
| Patients Not Treated with CerefolinNAC® | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Levels of Homocysteine Over Time
To analyze homocysteine levels, cognitive test scores and depression level to determine the prevalence of hyperhomocysteinemia and associated metabolic abnormalities and compare results of patients on Cerefolin NAC® alone to patients on Cerefolin NAC® in combination with standard of care memory and/or depression medications.
Measured: Week 6, Week 12, and Quaterly Thereafter @ 6 Month Intervals
Secondary outcomes (2)
To evaluate the safety and tolerability of Cerefolin NAC® based on adverse events, discontinuation due to intolerability and compliance.
Measured: Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals
Examine the demographics, medical co-morbidities present and affective and cognitive characteristics of the group of patients demonstrating hyperhomocysteinemia compared with the group without hyperhomocysteinemia in a dementia population.
Measured: Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamlab, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clionsky Neuro Systems Inc.
- Responsible party
- Sponsor
- Investigators
- Emily Clionsky, MD, Principal investigator, Clionsky Neuro Systems Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594541
- Sponsor's protocol ID
- NAC-004
- Status last verified
- Mar 2014
- First submitted
- 3 Apr 2012
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperhomocysteinemia in a Mild Cognitive Impairment and Dementia Population: the Effect of Treatment With Cerefolin NAC® in a Naturalistic Community-based Dementia Practice
- ClinicalTrials.gov ID
- NCT01594541
- Acronym / sponsor ID
- NAC-004
- Conditions
- Mild Cognitive Impairment
- Keywords
- hyperhomocysteinemia, dementia, depression, vitamin B12, mild cognitive impairment, alzheimer's
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Pamlab, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clionsky Neuro Systems Inc.
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Apr 2014 (estimated)
- First posted
- 9 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective analysis of de-identified data from 700 charts of consecutive patients from this patient population is to investigate the prevalence of hyperhomocysteinemia and associated metabolic abnormalities in this naturalistic grouping of patients with various stages of cognitive loss and diagnosed with various types of dementia.
Detailed description
A single-center, retrospective review of the medical charts of 700 de-identified elderly patients who underwent evaluation and treatment for cognitive loss including analysis of:
Laboratory values of interest: homocysteine, methylmalonic acid, CRP, BNP, CO2, TSH, Fe/TIBC, RPR/TPPA/FTA-ABS, and if available, folic acid and B12 levels ordered by primary care providers.
Neuropsychological tests of executive function, memory and affect:
- Wechsler Memory Scale-Revised (WMS-R) or Fourth Edition (WMS-IV)
- Logical Memory -Delayed Recall, Scaled Score
- Visual Reproduction-Delayed Recall, Scaled Score
- Shopping List Test, Delayed Recall
- Trailmaking A and B Tests
- Verbal Absurdities subtest of the Stanford Binet, Form L-M
- Proverbs Test
- Memory Orientation Screening Test
- Folstein Mini-Mental State Exam
- Geriatric Depression Scale, 15 items
Sub-group analysis of MRI volumetrics and PET scans when available. Sequentially pulled from June 1, 2009 to September 2011
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Treated with CerefolinNAC® | – | – |
| Patients Not Treated with CerefolinNAC® | – | – |
Who may qualify
- Ages
- 55 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical charts of 700 de-identified elderly patients who underwent evaluation and treatment for cognitive loss.
Key inclusion criteria (4 listed)
- Individuals between the ages of 55 and 89 years old
- Meeting criteria for Mild Cognitive Impairment or dementia with a minimum MOST score of 5 but not over 23
- Has a minimum of 3 months evaluation
- Able to undergo testing for cognition and complete the GDS
Key exclusion criteria (5 listed)
- Known allergy/intolerance to any ingredient in Cerefolin NAC®
- Substantial impediments to adherence, such as severe dementia without caregiver to administer medication
- Inability to swallow pill-form medication
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
- Hcy score lower than 11
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in Levels of Homocysteine Over Time
Time frame: Week 6, Week 12, and Quaterly Thereafter @ 6 Month Intervals
To analyze homocysteine levels, cognitive test scores and depression level to determine the prevalence of hyperhomocysteinemia and associated metabolic abnormalities and compare results of patients on Cerefolin NAC® alone to patients on Cerefolin NAC® in combination with standard of care memory and/or depression medications.
2 secondary outcomes
To evaluate the safety and tolerability of Cerefolin NAC® based on adverse events, discontinuation due to intolerability and compliance.
Time frame: Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals
Examine the demographics, medical co-morbidities present and affective and cognitive characteristics of the group of patients demonstrating hyperhomocysteinemia compared with the group without hyperhomocysteinemia in a dementia population.
Time frame: Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
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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.
Emily Clionsky, MD principal investigator
Clionsky Neuro Systems Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Pamlab, Inc. at 1 site 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Change from Baseline in Levels of Homocysteine Over Time (time frame: Week 6, Week 12, and Quaterly Thereafter @ 6 Month Intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2014.