Alzheimer Disease
Conditions
Interventions
This is a non-randomized, single-arm, open-label clinical study. Intervention group: 20 patients with Alzheimers disease classified as mild or moderate, after cognitive, functional and mood assessment
E02.831.535.488
Sponsors
Universidade Federal do ABC
Scientia Especialidades Médicas LTDA
Universidade Municipal de São Caetano do Sul
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with Alzheimer's disease according to the criteria of the National Institute on Aging – Alzheimer's Association (NIA-AA) and corroborated by cerebrospinal fluid biomarkers (decreased beta-amyloid, increased phosphorylated tau protein). Age 18 years or older. Both birth sexes. Classified by the Clinical Dementia Rating (CDR) scale as mild or moderate stage (CDR 1 or 2). On a stable dose of cholinesterase inhibitors (donepezil, rivastigmine, or galantamine) for at least four months. With treated depression, provided they are on a stable dose of antidepressants and in a euthymic state
Exclusion criteria
Exclusion criteria: Presence of relevant intracerebral pathologies, including vascular lesions with Fazekas score greater than 2, not related to Alzheimer's Disease (AD). Non-compliance with the protocol. Blood coagulation disorders. Use of oral anticoagulants. Treatment with corticosteroids in the last six weeks. Pregnancy. Breastfeeding. Epilepsy. Untreated depression. Score equal to or greater than 5 on the Geriatric Depression Scale
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| We expect to verify patient's tolerability to the treatment, as well as the effect of the intervention on cognition, mood and functionality. | — |
Countries
Brazil
Contacts
Public ContactSabrina Araujo de Franca
Instituto Paulista de Saúde para Alta Complexidade
Outcome results
None listed