Efficacy of Frankincense Extract on Mild Cognitive Impairment and Evaluation of Brain-Derived Neurotrophic Factor (BDNF) as a Biomarker for Diagnosis and Monitoring of Treatment Response: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial"

The effect of frankincense extract on mild cognitive impairment and evaluating brain-derived neurotrophic factor (BDNF)

This study is an interventional, randomized, parallel, and double-blind clinical trial that aims to evaluate the effectiveness of frankincense and investigate the role of BDNF as a biomarker for monitoring response to treatment in patients with mild cognitive impairment (MCI).

Sabzevar - This study is a randomized, parallel, and double-blind clinical trial in which patients with MCI, after screening, are randomly assigned to the frankincense or placebo group. BDNF levels and cognitive function are measured and compared at the beginning of the study and after the intervention.

Individuals referred to specialized neurology clinics or nursing homes with a diagnosis of MCI based on Petersen or DSM-5-TR criteria and MoCA/MMSE standard. Exclusion criteria during the study: Definite diagnosis of dementia, severe depression, use of known BDNF-altering drugs (e.g., some antidepressants at higher doses) in the last 3 months, active systemic inflammatory disease, severe liver/kidney impairment, or known allergy to Boswellia frankincense.

Standardized Boswellia spp. product (e.g., boswellic extract with a specified percentage of AKBA) at an appropriate daily dose (based on previous clinical studies, e.g., 300–600 mg/day based on the product standard) for 12 weeks.

1.Change in serum BDNF levels 2.Cognitive function 3.Quality of life and daily functioning (ADL/IADL) 4.Safety and tolerability of frankincense supplementation

Patients will be randomly allocated to two groups—intervention (frankincense extract) and control (placebo)—in a 1:1 ratio using randomized block randomization with a block size of 4. In each 4-patient block, two patients will be assigned to the intervention group and two to the control group, and the order of assignments within each block will be generated randomly by statistical software to ensure that the allocation sequence is unpredictable.

The intervention consisted of capsules containing Boswellia extract and placebo, which were identical in shape, color, size, odor, and packaging. The capsules were coded by a pharmacist or an independent investigator, and the group allocation code was kept in a sealed envelope by a third party. Randomization of participants to groups was performed using a randomization method, and the codes were not opened until the statistical analysis was completed. Cognitive assessments (MoCA/MMSE) and measurement of serum BDNF levels were performed by evaluators and the laboratory, who were unaware of the group allocation of participants. Data analysis was also performed based on anonymous codes.