Efficacy and Safety of MMFS in Early AD
- Conditions
- Alzheimer Disease
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: MMFS-205-SR
- Registration Number
- NCT03531684
- Lead Sponsor
- Neurocentria, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral inactive placebo twice daily for 24 weeks MMFS-205-SR MMFS-205-SR 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
- Primary Outcome Measures
Name Time Method Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) score Change from baseline at 24 weeks 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.
Neuropsychological Test Battery (NTB) standardized composite score Change from baseline at 24 weeks 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Modified Mini-Mental State Examination (mMMSE) total score Change from baseline at 12 and 24 weeks 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.
Alzheimer's Disease Cooperative Scale - Clinical Global Impression of Change (ADCS-MCI-CGIC) score Change from baseline at 12 and 24 weeks 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).
Neuropsychiatric Inventory (NPI) sub score Change from baseline at 12 and 24 weeks 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.
Trial Locations
- Locations (1)
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States