Aberrant Motor Behavior in Dementia
Conditions
Interventions
This is a pilot, randomized, placebo-controlled, double-blinded, with three arms, crossover clinical trial. Regarding blinding, the research was double-blind for the assessment of the primary outcomes
s disease, and non-pharmacological management of neuropsychiatric symptoms to ensure that the gold standard treatment was offered before considering the persistence of the
Sponsors
Universidade Federal de Sergipe
Universidade Federal de Sergipe
Eligibility
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: Elderly individuals; probable diagnosis of Alzheimer's disease; with aberrant motor behavior refractory to non-pharmacological measures
Exclusion criteria
Exclusion criteria: Use of implanted ferromagnetic devices; recent stroke; history of seizures; use of neuroleptics in the last 2 weeks; electrolyte disturbances; immobile; frail
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: An improvement is expected in the scores of the Neuropsychiatric Inventory of elderly people with dementia and Aberrant Motor Behavior (AMB).;Outcome 1: A lack of improvement was observed in the total intensity score of neuropsychiatric symptoms or specific improvement in the Aberrant Motor Behavior parameter | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: An improvement is expected in the Cognitive Assessment Scale (ADASCog), caregiver burden (Zaritz Scale), and a correlation between serum irisin concentration and variations in CMA parameter values ??on the Neuropsychiatric Inventory between the control and test groups;Outcome: It was observed that in cognitive outcomes, the (MMSE) showed consistent intra-individual changes, with a large effect size and confidence interval suggesting a shift towards clinical improvement (in the intervention group, median variation post- and pre-procedure of 3 points; 95% CI -0.56; 7.25, p = 0.034, r = 0.75). Regarding the ELISA outcome, there was relative stability of serum values ??in the intervention group (median variation post- and pre-procedure of +194.41 ng/mL; 95% CI -1617.75; 1843.88; p = 1.000, r = 0.00) and a statistically significant increase in the control group with a large effect size (median variation post- and pre-procedure of +580.35 ng/mL; 95% CI -333.94; 4410.54; p = 0.039, r = 0.73) | — |
Countries
Brazil
Contacts
Public ContactFilipe da Cruz
Universidade Federal de Sergipe
Outcome results
None listed