Evaluation of brain therapy for the treatment of Alzheimer's
- Conditions
- Alzheimer Disease
- Registration Number
- RBR-10g8337t
- Lead Sponsor
- Instituto Paulista de Saúde para Alta Complexidade
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Patients with Alzheimer's disease will be included, according to the NIA-AA criteria and corroborated by CSF biomarkers (decrease in beta-amyloid, increase in phosphorylated tau); Classified by the CDR scale in mild and moderate stages, that is, CDR 1 or 2; Patients should be on a stable dose of anticholinesterases for at least four months (donepezil, rivastigmine or galantamine); Patients with treated depression will be allowed, as long as they are on a stable dose of antidepressants and in a euthymic state; Patients will be assessed and selected from co-participating collection centers at the University of São Caetano do Sul and the University of São Paulo;
Exclusion criteria for treatment with TPS® will be relevant intracerebral pathologies (including Fazekas more than 2 vascular lesions) unrelated to AD; protocol noncompliance; blood clotting disorders; oral anticoagulation; corticosteroid treatment in the last 6 weeks; pregnancy; breastfeeding; epilepsy; untreated depression; individuals with scores equal to or greater than 5 on the geriatric blood pressure scale;
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To prospectively analyze the feasibility, safety and short-term effect of TPS® on the cognitive and emotional performance of patients with mild to moderate AD.
- Secondary Outcome Measures
Name Time Method We expect to verify patient's tolerability to the treatment, as well as the effect of the intervention on cognition, mood and functionality.