AnxietyPhase 2NCT03601169
Comparison of MMFS Dosages in Older Adults
A Phase 2 study testing Low Dose MMFS-205-SR and High Dose MMFS-205-SR in people with Anxiety and Depression, run by Neurocentria, Inc. at 1 site in United States.
Trial summary
This study is designed to compare the effectiveness of different doses of brain health supplement MMFS relative to placebo on cognition, mood, and sleep quality. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Anxiety, Depression, Sleep Quality
- What is being tested?
- Low Dose MMFS-205-SR and High Dose MMFS-205-SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2018to 31 Jan 2019
- Phase
- Phase 2
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged 60 to 85 inclusive at the time of screening with informed consent.
- Subjects with body weight within 50 to 125 kg and height within 152.4 to 198.12 cm, able to comply with study requirements; have received high school diploma, GED, or equivalent.
- Subjects must have regular access to an internet-connected computer, iPad, tablet computer, and/or smart phone to complete online assessments.
- Subjects with difficulty in maintaining sleep by the following criteria:
- Insomnia Severity Index (ISI) score ≥ 10 and ≤ 21
- 2 (moderate) or greater on question 2 OR question 3 of ISI
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- Subjects with at least "moderate" neuropsychiatric symptoms, as determined by a score of 6 or higher on the Mild Behavioral Impairment - Checklist (MBI-C) informant-report scale;
- Subjective report of worsened neuropsychiatric symptoms (e.g., MBI-C items such as motivation, depression, anxiety, impulse control, delusions) since age 50, with recent decline
- Score ≤ 7 and ≥ 4 on the D-KEFS Trail Making Test Condition 4 - letter-number switching test of executive function at screening, controlled for motor speed (condition 5)
- Subjective report of worsened memory since age 50, with recent decline
- Score of ≤ 7 and ≥ 4 on WMS-IV Logical Memory II (Delayed)
- Subjects must be fluent in English
- Subject must be willing to submit to blood draw(s).
- Subjects must be able to understand the study, agree to the requirements and restrictions, be able to attend all scheduled visits, and be willing to give voluntary consent to participate in the study.
Who cannot join
- Subject with insomnia due to bladder problems, or other confounding medical condition such as chronic pain syndromes, chronic migraine, cardiac disease, nocturia (> 3 times/night), asthma, gastroesophageal reflux disease (GERD), or hot flashes, determined by investigators.
- Subject diagnosed with severe sleep apnea that is not treated/well-managed (e.g., by regular use of Continuous Positive Airway Pressure, CPAP, or Bilevel Positive Airway Pressure, BIPAP, device)
- Subject's residence is an institutional facility such as a nursing home.
- Females of child-bearing potential as defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
- History or diagnosis of any of the following sleep conditions:
- Narcolepsy
Show all 22Show fewer
- Cataplexy (familial or idiopathic)
- Circadian Rhythm Sleep Disorder
- Primary Hypersomnia
- Subjects with history or presence of any clinically significant cardiovascular (myocardial infarction; coronary angioplasty or bypass graft(s); valvular disease or repair; unstable angina pectoris; transient ischemic attack (TIA); cerebrovascular accidents (CVA); congestive heart failure or coronary artery disease (CAD), clinically important carotid or vertebrobasilar stenosis or plaque, pulmonary, respiratory, hepatic, renal (including poor kidney function, eGFR <55 mL/min), hematological (sickle cell anemia or thalassemia, sideroblastic anemia or anemia of any etiology), gastrointestinal, endocrine (diabetes type I or II), immunologic, dermatologic, neurological, psychiatric disease or disorder within 6 months, or any uncontrolled medical illness which in the opinion of the Investigator would jeopardize the safety of the subject.
- Nonetheless, subjects with controlled co-morbid conditions (including diabetes, hypertension, heart disease, etc.) are permitted if considered stable within three months of the study start. All concomitant medications, supplements, or other substances must be at stable doses for at least 3 months prior to screening and must be kept as stable as medically possible during the trial.
- Any of the following based on clinician interview :
- Clinically significant psychiatric illness in past 6 months requiring hospitalization
- Other psychiatric condition that, in the investigator's opinion, would interfere with the subject's ability to participate in the study
- Suicidal ideation with intent, with or without a plan or method in the past 1 month or suicidal behavior in the past 6 months of Screening
- History of alcoholism or drug dependency/abuse within the last 5 years of Screening, according to interview
- Recent history (within the 6 months prior to Screening) of regular consumption (3 or more days per week) of either:
- 2 or more (women) or 3 or more (men) alcoholic beverages per day or alcohol consumption within 3 hours prior to bedtime
- More than 600 mg caffeine a day (e.g., 4 standard 8-ounce cups of brewed coffee, or typically consumes caffeine after 4pm [16:00])
- Known hypersensitivity to magnesium or to any of the formulation components (not including the common laxative effects of magnesium supplements)
- Currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent, or intent to participate in another clinical trial at any time during the conduct of this trial
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, 65802
About this study
Official title: Comparison of MMFS Dosages for Improving Cognition, Mood, and Sleep Quality in Older Adults
This study is designed to compare the effectiveness of different doses of brain health supplement MMFS relative to placebo on cognition, mood, and sleep quality.
Read the detailed description
This is a phase 2 study in older adults with at least mild progressive behavioral symptoms, subjective sleep maintenance problems, and at least mild progressive cognitive deficit. The study is a randomized, double-blind, placebo-controlled, three-way crossover design, in which participants will receive oral placebo, low dose MMFS, and high dose MMFS twice daily for 6 weeks. Over three study periods (2 weeks each), subjects will receive two different dosages of MMFS (low dose: ~22.5 mg/kg LBM/day and high dose: ~35 mg/kg LBM/day) and placebo. After periods 1 and 2 there will be a one week washout period in which the subject will not take any study tablets. Randomized patients and their informants (required) will complete 5 assessments total: at baseline in the clinic (visit 1; prior to taking any study tablets), and 4 times at home via online assessments (at the beginning of period 1 and at the end of periods 1, 2, and 3. The effectiveness of different MMFS dosages on cognition, mood, and sleep quality will be assessed using a Neuropsychological Test Battery, Profile of Mood States-Brief Form, daily sleep diaries, and Insomnia Severity Index. The safety profile of different MMFS dosages will be determined by monitoring the AE/SAE and subjective remarks during the study period. A range of safety and tolerability assessments will also be performed (including vital signs and laboratory tests).
- Conditions
- Anxiety, Depression, Sleep Quality, Cognitive Impairment
- Being tested
- Low Dose MMFS-205-SR, High Dose MMFS-205-SR, Placebo
- Keywords
- cognition, mood, sleep
- Medical subject headings
- Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose MMFS-205-SRDietary supplement
Also called L-threonic acid magnesium salt, L-TAMS
Twice daily, oral 500mg tablets
High Dose MMFS-205-SRDietary supplement
Also called L-threonic acid magnesium salt, L-TAMS
Twice daily, oral 500mg tablets
PlaceboDietary supplement
Also called inactive sugar pill
Twice daily, oral
| Study group | Role | What they receive |
|---|---|---|
| Low Dose MMFS-205-SR | Experimental | Low dose, oral MMFS-205-SR twice daily (1,000 or 1,500 mg/day total, depending on lean body mass: ~22mg/kg LBM/day) for 6 weeks Receives: Dietary Supplement: Low Dose MMFS-205-SR |
| High Dose MMFS-205-SR | Experimental | High dose, oral MMFS-205-SR twice daily (1,500 or 2,000 mg/day total, depending on lean body mass: ~33mg/kg LBM/day) for 6 weeks Receives: Dietary Supplement: High Dose MMFS-205-SR |
| Placebo | Placebo comparator | Oral inactive placebo twice daily for 6 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Test Battery (NTB; computerized, at home, on-line) composite score
NTB consists of 5 cognitive tests, including: 1) N-Back Test for working memory; 2) Trail Making Test (TMT) assessing psychomotor processing speed and cognitive flexibility; 3) Backwards Digit Span Test for working memory; 4) Digit Symbol Substitution Test (DSST) measuring psychomotor processing speed; and 5) Block Tapping Test assessing visuo-spatial working memory. For each test, scores will be normalized using a z-score transformation. The mean of the 5 z-scores for each subject will be compared between low dose MMFS, high dose MMFs, and placebo groups. A score of 0 designates average performance. Each point above 0 designates 1 standard deviation above average and each point below 0 designates 1 standard deviation below average.
Measured: 2 weeks each dose
Secondary outcomes (6)
Total Mood Disturbance (TMD) composite score measured by the Profile of Mood States - Brief Form (POMS-BF)
POMS-BF is a self-rated questionnaire on different moods over the past day. It consists of 30 questions pertaining to 6 domains of mood. Each question is rated on a 5-point scale (0-4). Lower scores indicate a better mood state. Comparison of the mean score between low dose MMFS, high dose MMFs, and placebo groups.
Measured: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Morning - Subjective Sleep Quality
Subjective measurements of daily anxiety by recording a daily diary (recorded in the morning) on a 10 point scale (1-10) with 1=Extremely poor and 10=Extremely good. Adapted from Consensus Sleep Diary.
Measured: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Morning - Refreshed Feeling
Subjective measurements of daily anxiety by recording a daily diary (recorded in the morning) on a 10 point scale (1-10) with 1=Extremely unrefreshed and 10=Extremely refreshed. Adapted from Consensus Sleep Diary.
Measured: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Evening - Subjective Anxiety
Subjective measurements of daily anxiety by recording a daily diary (recorded in the evening) on a 10 point scale (1-10) with 1=Extremely anxious and 10=Extremely relaxed. Adapted from Consensus Sleep Diary.
Measured: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Evening - Subjective Depression
Subjective measurements of daily anxiety by recording a daily diary (recorded in the evening) on a 10 point scale (1-10) with 1=Extremely depressed and 10=Extremely cheerful. Adapted from Consensus Sleep Diary.
Measured: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Evening- Subjective Cognitive Ability
Subjective measurements of daily anxiety by recording a daily diary (recorded in the evening) on a 10 point scale (1-10) with 1=Extremely poor and 10=Extremely good. Adapted from Consensus Sleep Diary.
Measured: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start23 Jul 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocentria, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald Burkindine, MD, Principal investigator, Bio-Kinetic Clinical Applications, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601169
- Sponsor's protocol ID
- NC010
- Status last verified
- Sep 2020
- First submitted
- 5 Jul 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of MMFS Dosages for Improving Cognition, Mood, and Sleep Quality in Older Adults
- ClinicalTrials.gov ID
- NCT03601169
- Acronym / sponsor ID
- NC010
- Conditions
- Anxiety, Depression, Sleep Quality, Cognitive Impairment
- Keywords
- cognition, mood, sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Neurocentria, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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 study is designed to compare the effectiveness of different doses of brain health supplement MMFS relative to placebo on cognition, mood, and sleep quality.
Detailed description
This is a phase 2 study in older adults with at least mild progressive behavioral symptoms, subjective sleep maintenance problems, and at least mild progressive cognitive deficit. The study is a randomized, double-blind, placebo-controlled, three-way crossover design, in which participants will receive oral placebo, low dose MMFS, and high dose MMFS twice daily for 6 weeks. Over three study periods (2 weeks each), subjects will receive two different dosages of MMFS (low dose: ~22.5 mg/kg LBM/day and high dose: ~35 mg/kg LBM/day) and placebo. After periods 1 and 2 there will be a one week washout period in which the subject will not take any study tablets. Randomized patients and their informants (required) will complete 5 assessments total: at baseline in the clinic (visit 1; prior to taking any study tablets), and 4 times at home via online assessments (at the beginning of period 1 and at the end of periods 1, 2, and 3. The effectiveness of different MMFS dosages on cognition, mood, and sleep quality will be assessed using a Neuropsychological Test Battery, Profile of Mood States-Brief Form, daily sleep diaries, and Insomnia Severity Index. The safety profile of different MMFS dosages will be determined by monitoring the AE/SAE and subjective remarks during the study period. A range of safety and tolerability assessments will also be performed (including vital signs and laboratory tests).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose MMFS-205-SR | Experimental | Dietary Supplement: Low Dose MMFS-205-SRLow dose, oral MMFS-205-SR twice daily (1,000 or 1,500 mg/day total, depending on lean body mass: ~22mg/kg LBM/day) for 6 weeks |
| High Dose MMFS-205-SR | Experimental | Dietary Supplement: High Dose MMFS-205-SRHigh dose, oral MMFS-205-SR twice daily (1,500 or 2,000 mg/day total, depending on lean body mass: ~33mg/kg LBM/day) for 6 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOral inactive placebo twice daily for 6 weeks |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female subjects, aged 60 to 85 inclusive at the time of screening with informed consent.
- Subjects with body weight within 50 to 125 kg and height within 152.4 to 198.12 cm, able to comply with study requirements; have received high school diploma, GED, or equivalent.
- Subjects must have regular access to an internet-connected computer, iPad, tablet computer, and/or smart phone to complete online assessments.
- Subjects with difficulty in maintaining sleep by the following criteria:
- Subjects with at least "moderate" neuropsychiatric symptoms, as determined by a score of 6 or higher on the Mild Behavioral Impairment - Checklist (MBI-C) informant-report scale;
Key exclusion criteria (22 listed)
- Subject with insomnia due to bladder problems, or other confounding medical condition such as chronic pain syndromes, chronic migraine, cardiac disease, nocturia (> 3 times/night), asthma, gastroesophageal reflux disease (GERD), or hot flashes, determined by investigators.
- Subject diagnosed with severe sleep apnea that is not treated/well-managed (e.g., by regular use of Continuous Positive Airway Pressure, CPAP, or Bilevel Positive Airway Pressure, BIPAP, device)
- Subject's residence is an institutional facility such as a nursing home.
- Females of child-bearing potential as defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
- History or diagnosis of any of the following sleep conditions:
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 |
|---|---|---|
| Low Dose MMFS-205-SRAlso: L-threonic acid magnesium salt, L-TAMSTwice daily, oral 500mg tablets | Dietary supplement | Low Dose MMFS-205-SR |
| High Dose MMFS-205-SRAlso: L-threonic acid magnesium salt, L-TAMSTwice daily, oral 500mg tablets | Dietary supplement | High Dose MMFS-205-SR |
| PlaceboAlso: inactive sugar pillTwice daily, oral | Dietary supplement | Placebo |
Primary outcome
Neuropsychological Test Battery (NTB; computerized, at home, on-line) composite score
Time frame: 2 weeks each dose
NTB consists of 5 cognitive tests, including: 1) N-Back Test for working memory; 2) Trail Making Test (TMT) assessing psychomotor processing speed and cognitive flexibility; 3) Backwards Digit Span Test for working memory; 4) Digit Symbol Substitution Test (DSST) measuring psychomotor processing speed; and 5) Block Tapping Test assessing visuo-spatial working memory. For each test, scores will be normalized using a z-score transformation. The mean of the 5 z-scores for each subject will be compared between low dose MMFS, high dose MMFs, and placebo groups. A score of 0 designates average performance. Each point above 0 designates 1 standard deviation above average and each point below 0 designates 1 standard deviation below average.
6 secondary outcomes
Total Mood Disturbance (TMD) composite score measured by the Profile of Mood States - Brief Form (POMS-BF)
Time frame: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Morning - Subjective Sleep Quality
Time frame: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Morning - Refreshed Feeling
Time frame: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Evening - Subjective Anxiety
Time frame: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Evening - Subjective Depression
Time frame: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Consensus Sleep Diary for Evening- Subjective Cognitive Ability
Time frame: 2 weeks each dose, mean of days 3-7 of week 2 in each of the 3 periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Donald Burkindine, MD principal investigator
Bio-Kinetic Clinical Applications, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low Dose MMFS-205-SR and High Dose MMFS-205-SR in people with Anxiety and Depression, run by Neurocentria, 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 14 inclusion and 22 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: finished, as of the sponsor's last update on 9 Sep 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neuropsychological Test Battery (NTB; computerized, at home, on-line) composite score (time frame: 2 weeks each dose). 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 9 Sep 2020.