Mild Cognitive Impairment
Conditions
Keywords
Physical frailty, Cognitive frailty, Cognitive impairment
Brief summary
The study is designed to evaluate the effects of choline bitartrate on cognitive impairment in frailty patients. The study will analyze the impact of 4 weeks treatment randomized with a nutraceutical compound in a double-blind randomized placebo controlled trial. The investigators will also assess cognitive frailty.
Detailed description
The patients and controls will be recruited at the Hypertension research center of Federico II university hospital. The overall duration of the study will be 4 weeks for each participant. Blood pressure, heart rate and cognitive frailty and cognitive impairment will be evaluated for each patient at randomization and after 4 weeks of treatment. Patients or controls will be randomized to receive the nutraceutical compound (1 vial of CEREBRAIN per os with 1200 mg of choline bitartrate every 24 hours) or placebo (1 vial per os without active substance every 24 hours). Before the start of treatment, patients will undergo full examination of cognitive functions (MoCA and MMSE tests, the parameters will be reported in a password-protected database, using a identification code. The duration of the treatment will be 4 weeks. At the end of the treatment, the patients will repeat the tests and the results will be identified through the use of an alphanumeric code (POST-XXXYYY). All CEREBRAIN and placebo, made up of the CEREBRAIN vehicle without the active substance, will be offered free of charge by the Farmaceutici DAMOR company.
Interventions
DRUGPlacebo oral vial
In the Placebo group the participants take vehicle (1 vial per os every 24 hours) for 4 weeks
In the CEREBRAIN group the participants take CEREBRAIN (1 vial per os of 1.2 g every 24 hours) for 4 weeks
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mild cognitive impairment
Exclusion criteria
Ictus Atrial fibrillation Kidney diseases Cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive functions | 4 weeks | Cognitive functions will be assessed by MoCA test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive frailty | 4 weeks | Cognitive frailty will be assessed by the Fried criteria (at least 3/5 criteria whether MCI is diagnosed with the Clinical Dementia Rating Scale (0 to 5) |
Countries
Italy
Outcome results
None listed