Comparative study of choline alfoscerate as a combination therapy with donepezil: A mixed double-blind randomized controlled and open-label observation trial

Topic: Brain proteins, microglia and lab models

Background Choline alfoscerate (alpha-glycerylphosphorylcholine) is a phospholipid that includes choline, which increases the release of acetylcholine. The ASCOMALVA trial, a combination of donepezil and choline alfoscerate, slowed cognitive decline in Alzheimer disease. This study aims to replicate the effect by combining donepezil with other nootropics currently used in South Korea. Methods The 119 patients with cognitive decline who were eligible to use donepezil, with an mini-mental state examination (MMSE) score of 26 or less, were assigned to: donepezil alone (DO); donepezil and choline alfoscerate (DN); donepezil and acetyl-l-carnitine (DA); or donepezil and ginkgo biloba extract (DG). Cognitive evaluations such as MMSE, clinical dementia rating, Alzheimer disease assessment scale-cognitive subscale (ADAS-Cog), and Alzheimer disease assessment scale-noncognitive subscale were performed at the 12th and 24th weeks from the baseline time point. Results At the 12th week, the MMSE score increased 3.52% in the DN group, whereas it increased by 1.36% in the DO group. In the DA + DG group, it decreased by 2.17%. At the 24th week, the MMSE score showed an increase of 1.07% in the DO group and 1.61% in the DN group, but decreased by 5.71% in the DA + DG group. ADAS-Cog decreased by 0.9% in the DO group, while it improved by 13.9% in the DN group at the 12th week. At the 24th week, ADAS-Cog showed improvement in the DN group by 18.5%, whereas it improved by 9.4% in the DO group. Alzheimer disease assessment scale-noncognitive subscale also revealed better performance in the DN group than in the DO group at the 12th and 24th weeks. Conclusion Choline alfoscerate exhibits additional cognitive improvement in both cognitive and noncognitive domains, supporting the findings of the ASCOMALVA trial.

@article{lee2024-38875437,
  author  = {Lee, W. and Kim, M.},
  title   = {{Comparative study of choline alfoscerate as a combination therapy with donepezil: A mixed double-blind randomized controlled and open-label observation trial}},
  journal = {Medicine},
  year    = {2024},
  doi     = {10.1097/md.0000000000038067},
  pmid    = {38875437},
  url     = {https://doi.org/10.1097/md.0000000000038067}
}

Key findings

• Results At the 12th week, the MMSE score increased 3.52% in the DN group, whereas it increased by 1.36% in the DO group.
• Alzheimer disease assessment scale-noncognitive subscale also revealed better performance in the DN group than in the DO group at the 12th and 24th weeks.

Why it matters

Adding choline alfoscerate to donepezil was linked to better memory and noncognitive scores than donepezil alone at 12 and 24 weeks in this small 119-patient trial. It does not show a cure or prevention, and the comparison with other nootropics was less clear.

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Study details

• Participants119
• Effect size3.52%; increased by 1.36%; decreased by 2.17%
• Evidence strengthLow

Read the original

• DOI: 10.1097/md.0000000000038067
• PubMed: 38875437
• Original source →
• Free full text: Medicine →

Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).

Studies this one cites

Referenced by this study and also in the alzhub library, so you can read them here.

• Cognitive improvement in mild to moderate Alzheimer's dementia after treatment with the acetylcholine precursor choline alfoscerate: a multicenter, double-blind, randomized, placebo-controlled trial Clinical therapeutics · 2003-01-01 · usefulness score 65/100 · Treatments
• The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease Alzheimer's & dementia : the journal of the Alzheimer's Association · 2011-04-21 · usefulness score 61/100 · Getting a diagnosis

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