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Alzheimer DiseasePhase 2NCT03531684

Efficacy and Safety of MMFS in Early AD

A Phase 2 study testing MMFS-205-SR in people with Alzheimer Disease, run by Neurocentria, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to evaluate the safety and efficacy of MMFS for improving cognition and global function in patients with probable Early Alzheimer's disease. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
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
10 participants
Where
1 siteUnited States
Study dates
20 Mar 2018to 22 Apr 2020
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 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients meeting all of the following inclusion criteria should be considered for admission to the study:
  • MMSE ≥ 19
  • ≥ 55 and ≤ 85 years old at Screening
  • Meet criteria for at least one of the following Stages of Early Alzheimer's Disease as defined below:
  • Stage 3 AD (MCI due to AD)
  • CDR Global score = 0.5, with
Show all 23Show fewer
  • 0.5 on memory box score; and
  • 0.5 on at least one of the following functional measures: community affairs, home \& hobbies, or personal care
  • MMSE ≥ 24
  • Stage 4 AD (Mild AD):
  • CDR Global score = 1, with
  • 0.5 on memory box score; and
  • 0.5 on at least one of the following functional measures: community affairs, home \& hobbies, or personal care; OR
  • CDR Global score = 0.5, with
  • 0.5 on memory box score; and
  • 0.5 on at least one of the following functional measures: community affairs, home \& hobbies, or personal care; and MMSE 19-23
  • ≥ 3 on at least one of the following Neuropsychiatric Inventory (NPI) behavioral areas: Agitation/Aggression, Depression/Dysphoria, Anxiety, Apathy/Indifference, Disinhibition, or Irritability/Lability, and total NPI score in these behavioral areas ≥ 6.
  • Total Body weight (bw) must be ≥50 kg and ≤110 kg and lean body mass (LBM) must be ≤ 85 kg at screening
  • Must be fluent in English
  • Must have a friend/family member who frequently spends time with the subject (≥10 hours per week), and is willing to serve as an informant, and accompany the subject to, and participate in, all clinic visits
  • Completion of at least 10 years of formal education (i.e., possess high school diploma, GED, or equivalent)
  • Hearing and Vision ability sufficient to complete neurocognitive testing
  • Be able and willing to collect urine (at home) for 12 hours the day prior to follow up visits (optional for Stage 4 patients).

Who cannot join

  • Patients meeting any of the following exclusion criteria will not be enrolled in the study:
  • Exclusions to rule out subjects with cognitive impairment likely due to something other than AD:
  • Known negative biomarker for brain amyloid pathology as indicated by either amyloid PET or CSF assessment or both
  • Stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
  • Clinically significant psychiatric illness in past 6 months requiring hospitalization
  • Seizure in the past 3 years
Show all 40Show fewer
  • Within 1 year before the screening or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (e.g., significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia; congenital QT prolongation
  • Subject report of human immunodeficiency virus (HIV) infection
  • History of evidence of acute or sub-acute micro or macrohemorrhage, greater than 4 microhemorrhages, cortical infarct, or greater than one 1 lunar infarct
  • Alcohol or substance abuse in past 1 year
  • Untreated and/or uncontrolled hypothyroidism
  • Evidence of vascular dementia (Modified Hachinski Ischemia Scale score >5)
  • History of clinically important carotid or vertebrobasilar stenosis or plaque
  • Systemic chemotherapy in past 1 year
  • Diagnosis of Multiple Sclerosis
  • Unintentional rapid weight loss (>10% body weight within past 12 months)
  • Exclusions to rule out subjects with potential issues absorbing or metabolizing MMFS:
  • Poor kidney function; corrected estimated glomerular filtration rate (eGFRcorr) < 40 mL/min/m2
  • History of significant gastrointestinal disorder, such as chronic Diarrhea, irritable bowel syndrome, ulcerative colitis, Chron's disease, etc.
  • Exclusions to rule out subjects with sleeping problems not related to CNS disorder:
  • Diagnosed with apnea/hypopnea but not using Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BIPAP). If diagnosed with apnea/hypopnea, subject must maintain use of device throughout study
  • Untreated nocturia that affects sleep
  • Exclusions to rule out subjects with conditions that could affect their safety:
  • Females of child-bearing potential, as defined as menstruation within past 12 months or not surgically sterile.
  • Systolic blood pressure > 150 mm Hg
  • An affirmative response on the C-SSRS, indicating suicidal ideation with intent, with or without a plan or method, or suicidal behavior, in the past 6 months.
  • Exclusions to rule out subjects with conditions that could inhibit or confound the effects of MMFS or the ability of the subject to complete the study:
  • Serious or unstable clinically important systemic illness or disease that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders
  • Currently living in an institutional facility such as a nursing home
  • History or diagnosis of any of the following sleep conditions:
  • Narcolepsy
  • Cataplexy (familial or idiopathic)
  • Circadian Rhythm Sleep Disorder
  • Primary Hypersomnia
  • Severe physical disability not associated with cognitive function that limits ability to complete neurocognitive testing (e.g., severe tremor, debilitating arthritis)
  • Changes in medications or doses of medication in past 30 days prior to Screening
  • All allowed concomitant medications, supplements, or other substances (with the exception of sleep, mood, cognitive and neuropsychiatric drugs) must be at stable doses for at least 30 days prior to screening and must be kept as stable as medically possible during the trial. Dosing change of ConMeds within 30 days of Screening may be allowed if in the opinion of the investigator, will not affect or influence study results.
  • If a change in medication dosage occurs during the study, this will lead to discontinuation from study participation unless it relates to a medication that, in the view of the study investigator, does not affect participation in the trial.
  • Allowed Sleep, Neuropsychiatric and Cognitive drugs must be stable for 90 days prior to Screening. Dosing change of Neuropsychiatric and Cognitive drugs within 90 days of Screening may be allowed if in the opinion of the investigator, will not affect or influence study results.
  • Use of prohibited medications/substances.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Clinical Trial to Test the Efficacy and Safety of MMFS-205 in Early Alzheimer's Disease Patients

This study is designed to evaluate the safety and efficacy of MMFS for improving cognition and global function in patients with probable Early Alzheimer's disease.

Read the detailed description

This is a phase 2 study in patients with probable Early Alzheimer's disease (AD). Early AD includes Stage 3 AD patients (MCI due to AD) and Stage 4 AD patients (mild AD). The study is a randomized, double-blind, placebo controlled, parallel group design, in which participants (up to 6 per arm; 12 total) will receive oral placebo or MMFS twice daily for 24 weeks. Randomized patients and their informants (required) will complete 3 assessments total: at baseline (prior to taking any study tablets), week 12, and week 24 visits. At each of the three visits, participants will complete cognitive and behavioral measures and clinical interviews, a blood sample will be collected for safety and biomarkers related to Alzheimer's disease, and the informant will complete an interview concerning the patient's cognition, mood, and function. A range of safety and tolerability assessments will also be performed (including vital signs, laboratory tests, and ECGs). Participants will be contacted by phone between clinical assessments for monitoring.

Being tested
MMFS-205-SR, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

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

  • MMFS-205-SRDietary supplement

    Also called L-threonic acid magnesium salt, L-TAMS

    Twice daily, oral, 500 mg tablets

  • PlaceboDietary supplement

    Also called Inactive sugar pill

    Twice daily, oral

Study groups in NCT03531684
Study groupRoleWhat they receive
MMFS-205-SRExperimentalOral MMFS-205-SR twice daily (2,000, 3,000, or 4,000 mg/day total, depending on lean body mass and response to initial dose at Week 12) for 24 weeks
Receives: Dietary Supplement: MMFS-205-SR
PlaceboPlacebo comparatorOral inactive placebo twice daily for 24 weeks
Receives: Dietary Supplement: Placebo

What is being measured

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

  1. Neuropsychological Test Battery (NTB) standardized composite score

    Standardized composite score generated from a battery of 4 cognitive tests, including: 1) COWAT - Category Fluency assessment of semantic fluency; 2) WAIS-IV Coding (Digit Symbol Substitution Test; DSST) assesment of attention speed of processing, mental flexibility and executive function; 3) Free and Cued Selective Reminding Test Immediate Recall (FCSRT-IR) assessment of episodic visual memory; 4) Wechsler Logical Memory II (Delayed Recall) assessment of narrative memory.

    Measured: Change from baseline at 24 weeks

  2. Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) score

    Composite measure of cognition and global function. The scores in each domain range from 0-3, referring to impairment with 0 being none, 0.5 being questionable, 1 being mild, 2 being moderate, and 3 being severe.

    Measured: Change from baseline at 24 weeks

Secondary outcomes (4)

  1. Modified Mini-Mental State Examination (mMMSE) total score

    Cognitive test; the mMMSE is scored as the number of correctly completed items, with lower scores indicative of poorer performance and greater cognitive impairment. The score ranges from 0 to 100, with 100 being perfect performance. An mMMSE-derived MMSE score ranging from 0 to 30, with 30 being perfect performance, can also be generated.

    Measured: Change from baseline at 12 and 24 weeks

  2. Alzheimer's Disease Cooperative Scale-Activities of Daily Living-Mild Cognitive Impairment 24 questions (ADCS-ADL-MCI24)

    Survey assessing daily function; scores range from 0 to 53 for the ADL section and 0 to 16 for the instrumental ADL section, with lower scores demonstrating more functional impairment.

    Measured: Change from baseline at 12 and 24 weeks

  3. Alzheimer's Disease Cooperative Scale - Clinical Global Impression of Change (ADCS-MCI-CGIC) score

    Clinical assessment of global function. The Clinician's Global Impression of Change Scale (ADCS-MCI-CGIC) is rated on a 7-point scale with the change scale using a range of responses from 1 (very much improved) through 7 (very much worse).

    Measured: Change from baseline at 12 and 24 weeks

  4. Neuropsychiatric Inventory (NPI) sub score

    Informant interview assessment of patient's neuropsychiatric symptom severity. The score for each domain is defined as frequency times severity and total NPI score is defined as the sum of the individual category scores. Higher scores on NPI indicate a more frequent and/or severe presence of neuropsychiatric behavioral changes. The following domains will be included in the subscore: Depression/Dysphoria, Anxiety, Apathy/Indifference, Irritability/Lability, Agitation/Aggression, and Disinhibition.

    Measured: Change from baseline at 12 and 24 weeks

Timeline

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

  1. First posted22 May 2018
  2. Study start20 Mar 2018
  3. Primary completion22 Apr 2020
  4. Study completion22 Apr 2020

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03531684
Sponsor's protocol ID
NC007
Status last verified
Sep 2020
First submitted
4 Apr 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MMFS-205-SR in people with Alzheimer Disease, 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 23 inclusion and 40 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) standardized composite score (time frame: Change from baseline at 24 weeks). The study lists 2 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 NCT03531684.

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.

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