Mild Cognitive Impairment Clinical Trial
Official title:
Randomized Controlled Trial to Evaluate the Efficacy of a Food Supplement, in Subjects With Mild Cognitive Impairment (MCI)
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.
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.
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