Clinical trial NCT03581929: Efficacy of MEMORMAX in Subjects With MCI
Official title: Randomized Controlled Trial to Evaluate the Efficacy of a Food Supplement, in Subjects With Mild Cognitive Impairment (MCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Dementia
Memormax
Food Supplement
Microbiota
Lead sponsor: Aboca Spa Societa' Agricola
Sponsor class: INDUSTRY
Collaborators: name: Latis S.r.l.
First posted: 2018-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a single-center, randomized, double-blinded placebo for the first 6 months of treatment in subjects with mild cognitive impairment. Open-label treatment, with all subjects receiving active treatment, for the next 6 months of study.

Detailed description: Patients are enrolled in the department of Geriatria, Azienda Ospedaliera di Perugia. The group of this pilot project will include 50 subjects. All the volunteers who, in compliance with the inclusion and exclusion criteria, will be available for follow-up at twelve months and are able to give informed written consent guaranteeing adherence to the treatment will be enrolled in the study.

The study involves the collection of clinical data acquired as part of routine assessments for the type of subject included in this research project.

Visit 1 baseline: day 1 (time 0) Upon enrollment, all subjects, for whom informed consent will be obtained, will undergo a medical examination for an overall assessment of the state of health. In all subjects, a careful family, pathological and pharmacological anamnesis will be collected, data on the habits of life (nutrition, smoking, exercise) will be collected through a specific questionnaire and the main anthropometric parameters will be evaluated (weight, height,body mass index, waist / hip ratio) and the risk of development of cognitive impairment through the Brief Late-life Dementia Risk Index (Barnes et al., 2014).

The clinical examination will be completed by a standard assessment for the hematobiochemical and urinalysis examinations.

The results of the tests and of the tests carried out for the diagnosis of MCI, according to the clinical practice of the center, will be collected and used as baseline values, up to one month before entry into the study.

In addition, some physical performance tests will be performed (hand grip evaluation, timed up and go, SPPB, frailty index, bioimedenzometry (BIA)). The results of the following tests and examinations carried out for the diagnosis of MCI will be collected, in the month before entry into the study: ECG, physical performance test (through evaluation of ADL, IADL), cognitive performance test (FCSRT, MMSE, ACE -R, Digit Span forward, Digit Span back, Trail Making A and B, Babcock story, Rey test, Raven test, Token test, verbal fluency test, prose memory, copy of drawings, verbal reviews), tests for the presence of behavioral disorders (Neuropsychiatric Inventory scale, NPI) and mood (Geriatric Depression Scale, GDS), Cognitive Reserve Index (CRI) (Nucci et al., 2012) in order to verify if the cognitive reserve could somehow to explain the variability found.

At this visit the patient will be randomized to receive one of the following products daily for 6 months:

A) Memormax, 2 vials / day B) Placebo, 2 vials / day. Each patient will receive a supply of 30 packs of 12 vials each of Memormax or Placebo. Finally, the material for stool collection will be delivered to the patients. Patients will then be instructed to not start treatment in the study before collecting the faecal sample. This sample must be returned to the center in the days immediately following the visit 1.

Visit 2 - time 6 months (± 5 days) After 6 months all subjects will be subjected to medical evaluation (functional and cognitive), venous blood sampling, urine test and ECG control. Any changes in concomitant therapies and any adverse events will be recorded. Unused and used vials will be collected for accounting and verification of treatment compliance. All the subjects in the study (n = 50) will receive for the next 6 months only Memormax, according to an open study design. Each patient will receive a supply of 30 packs of 12 vials each of Memormax.

Visit 3 - time 12 months (end of study / premature termination of the study) At twelve months, all subjects will be subjected to medical evaluation (functional and cognitive), peripheral venous blood sampling, urine test and ECG control. Any changes in concomitant therapies and any adverse events will be recorded. Unused and used vials will be collected for accounting and verification of treatment compliance. In the event of premature termination of the study by a patient, at any time after the start of treatment, all assessments scheduled for Visit 3 should be made, considering the visit itself as the conclusion of the study for that patient. It is specified that in the follow-up evaluations (6 and 12 months) the parallel versions of the instruments used at the baseline will be used to avoid learning effects.

Eligibility criteria: Inclusion Criteria:

* Subjects with mild cognitive impairment, according to operational criteria for defining Mild Cognitive Impairment (MCI) (Albert et al, 2011): change in cognitive status, mild deficit in one or more cognitive domains, normal ability to perform activities in daily life or slight deficits not related to cognitive reasons, absence of dementia;
* MMSE≥24
* Good level of functional autonomy: ADL ≥ 5 / 6, IADL ≥ 4 / 8 for male subjects, ≥ 6/8 for female subjects, SPPB with score ≥ 9; Walk speed test in 6 meters ≥ 1 m / s;
* Written informed consent of the patient.

Exclusion Criteria:

* Subjects with malignant neoplasia in progress or diagnosed within 5 years;
* Subjects with active infections or autoimmune pathogenesis diseases (eg sclerosis, Chron, polymyalgia);
* Subjects diagnosed with neurodegenerative disease in pharmacological treatment (eg Parkinson's disease)
* Subjects with psychiatric conditions (eg psychosis, depression, schizophrenia)
* Subjects in pharmacological treatment for urinary incontinence
* Subjects with involuntary weight loss\> 5 kg in the last twelve months;
* Subjects with chronic renal failure ≥ stage III K-DOQI;
* Subjects with clinically significant liver disease (AST / SGOT, ALT / SGPT\> 2 upper limits)
* Subjects with severe hearing, vision, speech or walking disabilities;
* Geriatric Depression Scale (Geriatric Depression Scale)\> 4 out of 15 items;
* Consumption in the two months prior to the baseline assessment of supplements containing omega-3 fatty acids or foods containing fish oil, foods for special medical purposes (AFMS);
* Use in the month prior to baseline assessment of: atropine, scopolamine, tolterodine, iosciamin, biperidene, benzotropin, oxybutynin, antipsychotics, vitamins B, C and / or\> at 200% of the suggested daily dose, highly energetic nutritional supplements and / or proteins, other products under experimentation;
* Alcohol abuse.
* Use of antibiotics in the two months preceding the baseline assessment;
* Regular use of probiotics, fiber supplements or laxative

Primary outcomes:
measure: Memormax efficacy on global cognitive performance (FCRST).
timeFrame: Day 0-180
measure: Memormax efficacy on global cognitive performance (ACE-R).
timeFrame: Day 0-180
measure: Effect of Memormax on global cognitive performance across the entire population (FCRST)
timeFrame: Day 181-360
measure: Effect of Memormax on global cognitive performance across the entire population (ACE-R)
timeFrame: Day 181-360
Secondary outcomes:
measure: variations of the main parameters of cognitive performance (MMSE)
timeFrame: Day 0-180-360
measure: variations of the main parameters of cognitive performance (Digit Span)
timeFrame: Day 0-180-360
measure: variations of the main parameters of cognitive performance (Trail Making)
timeFrame: Day 0-180-360
measure: variations of the main parameters of cognitive performance (Babcock)
timeFrame: Day 0-180-360
measure: variations of the main parameters of cognitive performance (Rey Test)
timeFrame: Day 0-180-360
measure: variations of the main parameters of cognitive performance (Raven Test)
timeFrame: Day 0-180-360
measure: variations of the main parameters of cognitive performance (Token Test)
timeFrame: Day 0-180-360
measure: variations of the main parameters of cognitive performance (Verbal Fluency)
timeFrame: Day 0-180-360
measure: variations of the main parameters of cognitive performance (NEPSY-II)
timeFrame: Day 0-180-360
measure: variations of the main parameters of cognitive performance (NPI)
timeFrame: Day 0-180-360
measure: variations of the main parameters of cognitive performance (GDS)
timeFrame: Day 0-180-360
measure: variations of the main parameters of cognitive performance (Cognitive Reserve Index)
timeFrame: Day 0-180-360
measure: variations of physical performance (BIA)
timeFrame: Day 0-180-360
measure: variations of physical performance (hand grip)
timeFrame: Day 0-180-360
measure: variations of physical performance ( timed up and go)
timeFrame: Day 0-180-360
measure: variations of physical performance (SPPB)
timeFrame: Day 0-180-360
measure: variations of physical performance (Frailty index)
timeFrame: Day 0-180-360
measure: variations of physical performance (ADL)
timeFrame: Day 0-180-360
measure: variations of physical performance (IADL)
timeFrame: Day 0-180-360
measure: variations of modification of biochemical parameters of inflammation.
timeFrame: Day 0-180-360
measure: variations of modification of oxidative stress conditions parameters.
timeFrame: Day 0-180-360
measure: variations of changes in the microbiota (bacteria subpopulations)
timeFrame: Day 0-180-360
measure: variations of changes in the microbiota (SCFA)
timeFrame: Day 0-180-360
measure: Safety and Tolerability (Adverse Events)
timeFrame: Day 0 to Day 360
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: S.C. di Geriatria Ospedale S. Maria della Misericordia
Study officials:
References: