Efficacy and Safety of MMFS in Early AD

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT03531684

Run by

Neurocentria, Inc.

People needed

10

Starts

2018-03-20

Expected to finish

2020-04-22

Last updated by the study team

2020-09-09

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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).

You may not qualify if…

• 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
• 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

Where it is running

• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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