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Potential synergistic effect between Fortasyn Connect and cholinesterase inhibitors in patients with early stages (very mild and mild) of dementia due to Alzheimer disease in common medical practice: An observational, non‐interventional study
Author(s) -
Fernandez Felix Vinuela,
Crespo Angeles Barro
Publication year - 2020
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1002/alz.040257
Subject(s) - cholinesterase , dementia , clinical dementia rating , observational study , medicine , disease , rating scale , informed consent , pharmacology , psychology , alternative medicine , pathology , developmental psychology
Background Details implementation of an innovative care program or practice: Fortasyn connect medical food, approved for early stages of Alzheimer dementia, can have a synergistic effect with cholinesterase inhibitors drugs. Objectives To analyse the possible synergistic effect between Fortasyn Connect medical food and Cholinesterase Inhibitors drugs in Alzheimer disease patients in a common medical practice. Patients and Methods 60 patients at early stages of dementia due to Alzheimer disease were followed. CDR (Clinical Dementia Rating) scale was administered at the beginning and at the end of the follow‐up period. The rate of change of CDR‐SB (sum of Blocks) was chosen as a efficacy criteria. Informed Consent was aquired. An approval of the Ethical Committee of the protocol was obtained. SSPS (v20) was used as a Statistical Software. Results The combination therapy with Fortasyn Connect and Cholinesterase inhibitors was well tolerated. There were no significative advers effect. The patients were distribute at the final visit in 4 groups: Those who had taken both Fortasyn Connect and Cholinesterase inhibitors (Group 1), those who had taken Fortasyn Connect and no Cholinesterase inhibitors (Group 2), those who had taken Cholinesterase inhibitors and non Fortasyn Connect (Group 3), those who had not taken neither Fortasyn Connect nor Cholinesterase inhibitors (Group 4). There was a statistical difference between the Group 1 with the Group 3 and Group 4, indicating a potential synergistic effect between both therapies. Conclusions The combination therapy with Fortasyn Connect medical food and Cholinesterase inhibitors was well tolerated. It seem to be a potential synergistic efect between Fortasyn Connect medical food and Cholinesterase inhibitors Drugs. An statistical difference between the Group 1 (Fortasyn Connect medical food and Cholinesterase inhibitors therapy) with the Group 3 (Cholinesterase Inhibitor alone) and Group 4 (Fortasyn Connect medical food and Cholinesterase inhibitors therapy), indicating a potential synergistic effect between both therapies. Due to the limitations of this preliminary study (non‐blinded, non randomized, small sample of patients, non placebo control), more studies are needed.