A RANDOMIZED CLINICAL TRIAL OF LOW-DOSE CANNABIS EXTRACT IN ALZHEIMER'S DISEASE
 
   

A Randomized Clinical Trial of Low-dose
Cannabis Extract in Alzheimer's Disease

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:
   Frankp@chiro.org
 
   

FROM:   J Alzheimers Dis 2025 (Dec); 108 (4): 1602–1613 ~ FULL TEXT

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Rafael de Morais Cury • Taynara da Silva • Fernando Cezar-Dos-Santos • Yasmin Rafaela Correia Fakih
Karlin Andrea Ramírez Narvaez • Murilo Chaves Gouvea, et al.

Laboratório de Cannabis e Psicodélicos,
School of Medicine,
Universidade Federal da Integração Latino-Americana,
Foz do Iguaçu, PR, Brazil.



SOURCE:   The Conversation

Background:   Preclinical and clinical evidence suggest that low-dose cannabinoids could ameliorate Alzheimer's disease (AD) signs and symptoms. We designed this trial to evaluate the safety and efficacy of low-dose THC-CBD balanced cannabinoid extract in the treatment of patients with AD-associated dementia.

Objective: The objective of this phase 2 trial was to evaluate the safety and efficacy of a balanced THC-CBD cannabinoid extract for symptomatic patients with AD.

Methods: A Phase 2, randomized, double-blind, placebo-controlled, clinical trial including patients between 60 and 80 years-old diagnosed with AD-associated dementia. For 26 weeks, participants orally received either placebo or THC-CBD extract (0.350 mg/THC and 0.245 mg/CBD), daily.

Results: At week 26, Mini-Mental State Exam total score was significantly higher in cannabis- when compared to placebo-treated patients, which was assessed using the mixed model analysis. No significant difference was detected between placebo and cannabis groups in terms of secondary outcomes and adverse events incidence.

Conclusions: To this date, this is the longest clinical trial evaluating cannabinoids effects on AD patients. We initially demonstrate that low-dose THC-CBD potentially can be an effective and safe therapeutic option for AD-related dementia. Nonetheless, larger and longer trials are necessary to confirm this finding and establish cannabinoid administration as therapy for AD dementia.

Keywords: Trial RegistrationThe Brazilian Registry of Clinical Trials (ReBEC) registration #U1111-1258-2058 - REBEC (ensaiosclinicos.gov.br).

Keywords:   Alzheimer's disease; Mini-Mental State Examination; cannabinoids; dementia; memory.



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