Alzheimer Disease
Conditions
Interventions
Longitudinal study: randomized,double-blind,placebo-controlled clinical trial.The calculation of the sample size was based on the study by WU et al (2015,using the statistical program G*Power 3.1®.The
or (b) the control group receiving the usual treatment,which consists of drug treatment recommended for dementia syndrome,including but not limited to prescribing anticholinesterase drugs (donepezil,
E02.621.820
Sponsors
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Eligibility
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of dementia,Complementary imaging exam for the diagnosis of dementia;either Alzheimer's Dementia, Mixed,Frontotemporal Lobar Degeneration,Lewy bodies, among others;use of acetylcholinesterase inhibitors and or memantine in doses stable for at least 3 months;clinical dementia rating = 2;the patient must be able to communicate,read and understand the term informed consent and be able to carry out assessments neuropsychological
Exclusion criteria
Exclusion criteria: Comorbidity with previously diagnosed psychiatric illness,contraindications to performing the neuromodulation method non-invasive like epilepsy,metal brain implants, non-removable metallic implants, cardioverter defibrillators,implantable devices, trauma or brain tumor;decompensated clinical disease like neoplasms, heart disease, pulmonary, hepatic, renal,and endocrine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be global cognition as measured using the Alzheimer's Disease Assessment Scale cognitive(ADAS-Cog).Statistical significance levels set at p<0.05. Means and standard deviation will be used to describe the test results. Comparisons of demographic and clinical variables between different groups will be analyzed using analysis of variance(ANOVA)for continuous variables and the chi-square test for categorical variables. Predictors of response to treatment,including clinical variables such as duration of illness, severity of the dementia syndrome,other clinical and demographic variables,will be included in the proposed statistical analysis modelIt is expected to find a reduction in the Adas-cog scores at the end of the study and maintenance of the scores 3 months later | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome will be on behavioral symptoms with the Neuropsychiatric Inventory (NPI) and depression inventory with the GDS 15(PDF version) Portuguese validated and reduced).Quality of life measures were carried out using the Quality of Life scaleLives of patients with Alzheimer's (QoL-AD),impact of diagnosis with the Impact Assessment scale Psychosocial Diagnosis of Dementia (AIPDD) and caregiver burden measured by the Zarit Burden InterviewStatistical significance levels set at p<0.05. Means and standard deviation will be used to describe the test results. Comparisons of demographic and clinical variables between different groups will be analyzed using analysis of variance(ANOVA) for continuous variables and the chi-square test for categorical variables.Predictors of response to treatment,including clinical variables such as duration of illness,severity of the dementia syndrome,other clinical and demographic variables, will be included in the proposed statistical analysis model. At the end of the study,it is expected to find a reduction in the total score of the NPI, as well as a reduction in the scores of the other cited scales | — |
Countries
Brazil
Contacts
Public ContactValeska Rodrigues
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Outcome results
None listed