Efficacy of MEMORMAX in Subjects With MCI

NCT03581929 | Completed

• 1 other identifier: MEMORMAX
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Dementia; Memormax; Food Supplement; Microbiota

Outcome Measures

Primary Outcomes (4)

• Memormax efficacy on global cognitive performance (FCRST).

  Effect of Memormax on global cognitive performance in patients with mild Mild Cognitive Impairment (MCI) after a 6 months treatment and compared to placebo (T0-T6), measured by the FREE AND CUED SELECTIVE REMINDING TEST (FCRST)

  Day 0-180

• Memormax efficacy on global cognitive performance (ACE-R).

  Effect of Memormax on global cognitive performance in patients with mild Mild Cognitive Impairment (MCI) after a 6 months treatment and compared to placebo (T0-T6), measured by the ADDENBROOKE'S COGNITIVE EXAMINATION (ACE-R) tests.

  Day 0-180

• Effect of Memormax on global cognitive performance across the entire population (FCRST)

  To evaluate the effect of Memormax on global cognitive performance across the entire population studied in a 6-month open-label extension phase (T6-T12), measured by the FCSRT

  Day 181-360

• Effect of Memormax on global cognitive performance across the entire population (ACE-R)

  To evaluate the effect of Memormax on global cognitive performance across the entire population studied in a 6-month open-label extension phase (T6-T12), measured by the ACE-R

  Day 181-360

Secondary Outcomes (24)

• variations of the main parameters of cognitive performance (MMSE)

  Day 0-180-360

• variations of the main parameters of cognitive performance (Digit Span)

  Day 0-180-360

• variations of the main parameters of cognitive performance (Trail Making)

  Day 0-180-360

• variations of the main parameters of cognitive performance (Babcock)

  Day 0-180-360

• variations of the main parameters of cognitive performance (Rey Test)

  Day 0-180-360

Study Arms (2)

Memormax

EXPERIMENTAL

2 vials / day of Memormax from Day 0 to Day 180. At the end of the blinded phase (Day 0-180), all patients will receive 2 vials / day of Memormax from Day 181 to Day 360.

Dietary Supplement: Memormax

Placebo

PLACEBO COMPARATOR

2 vials / day of Placebo from Day 0 to Day 180. At the end of the blinded phase (Day 0-180), all patients will receive 2 vials / day of Memormax from Day 181 to Day 360.

Other: Placebo

Interventions

Memormax DIETARY_SUPPLEMENT

Memormax is a food supplement indicated to support cognitive functions thanks to the Melissa officinalis; it also contains lyophilized Royal Jelly, Blueberry extract and Blueberry juice.

Memormax

Placebo OTHER

Placebo comparator

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aboca Spa Societa' Agricola: lead
• Latis S.r.l.: collaborator

Study Sites (1)

S.C. di Geriatria Ospedale S. Maria della Misericordia

Perugia, 06156, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind from Day 0 to Day 180. Open Label from Day 181 to Day 360.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: July 10, 2018
• Study Start: November 20, 2017
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)