Efficacy and Safety of MMFS in Early AD

NCT03531684 | Completed Phase 2

• 1 other identifier: NC007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from baseline at 24 weeks

• 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.

  Change from baseline at 24 weeks

Secondary Outcomes (4)

• Modified Mini-Mental State Examination (mMMSE) total score

  Change from baseline at 12 and 24 weeks

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

  Change from baseline at 12 and 24 weeks

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

  Change from baseline at 12 and 24 weeks

• Neuropsychiatric Inventory (NPI) sub score

  Change from baseline at 12 and 24 weeks

Other Outcomes (9)

• Physical Activity Scale for the Elderly (PASE)

  Change from baseline at 12 and 24 weeks

• Geriatric Depression Scale (GDS)

  Change from baseline at 12 and 24 weeks

• Brief Smell Identification Test (BSIT) score

  Change from baseline at 12 and 24 weeks

Study Arms (2)

MMFS-205-SR

EXPERIMENTAL

Oral 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

Dietary Supplement: MMFS-205-SR

Placebo

PLACEBO COMPARATOR

Oral inactive placebo twice daily for 24 weeks

Dietary Supplement: Placebo

Interventions

MMFS-205-SR DIETARY_SUPPLEMENT

Twice daily, oral, 500 mg tablets

Also known as: L-threonic acid magnesium salt, L-TAMS

MMFS-205-SR

Placebo DIETARY_SUPPLEMENT

Twice daily, oral

Also known as: Inactive sugar pill

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• on memory box score; and
• 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
• on memory box score; and
• on at least one of the following functional measures: community affairs, home \& hobbies, or personal care; OR
• CDR Global score = 0.5, with
• on memory box score; and
• on at least one of the following functional measures: community affairs, home \& hobbies, or personal care; and MMSE 19-23

You may not qualify if:

• 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)
• Poor kidney function; corrected estimated glomerular filtration rate (eGFRcorr) \< 40 mL/min/m2

Sponsors & Collaborators

• Neurocentria, Inc.: lead
• Ohio State University: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

threonic acid

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Douglas W Scharre, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: May 22, 2018
• Study Start: March 20, 2018
• Primary Completion: April 22, 2020
• Study Completion: April 22, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)