Interventional Study to Evaluate the Clinical Effects and Safety of the Nutraceutical Compound BrainUp-10® in a Cohort of Patients with Alzheimer's Disease: A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Trial.
J Alzheimers Dis
; 81(3): 1231-1241, 2021.
Article
em En
| MEDLINE
| ID: mdl-33935080
ABSTRACT
BACKGROUND:
Clinically-evaluated nutraceuticals are candidates for Alzheimer's disease (AD) prevention and treatment. Phase I studies showed biological safety of the nutraceutical BrainUp-10®, while a pilot trial demonstrated efficacy for treatment. Cell studies demonstrated neuroprotection. BrainUp-10® blocks tau self-assembly. Apathy is the most common of behavioral alterations.OBJECTIVE:
The aim was to explore efficacy of BrainUp-10® in mitigating cognitive and behavioral symptoms and in providing life quality, in a cohort of Chilean patients with mild to moderate AD.METHODS:
The was a multicenter, randomized, double blind, placebo-controlled phase II clinical study in mild to moderate AD patients treated with BrainUp-10® daily, while controls received a placebo. Primary endpoint was Apathy (AES scale), while secondary endpoints included Mini-Mental State Examination (MMSE), Trail Making Test (TMT A and TMT B), and Neuropsychiatry Index (NPI). AD blood biomarkers were analyzed. Laboratory tests were applied to all subjects.RESULTS:
82 patients were enrolled. The MMSE score improved significantly at week 24 compared to baseline with tendency to increase, which met the pre-defined superiority criteria. NPI scores improved, the same for caregiver distress at 12th week (pâ=â0.0557), and the alimentary response (pâ=â0.0333). Apathy tests showed a statistically significant decrease in group treated with BrainUp-10®, with pâ=â0.0321 at week 4 and pâ=â0.0480 at week 12 treatment. A marked decrease in homocysteine was shown with BrainUp-10® (pâ=â0.0222).CONCLUSION:
Data show that BrainUp-10® produces a statistically significant improvement in apathy, ameliorating neuropsychiatric distress of patients. There were no compound-related adverse events. BrainUp-10® technology may enable patients to receive the benefits for their cognitive and behavioral problems.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Suplementos Nutricionais
/
Doença de Alzheimer
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article