The Effect of the Association between Donepezil and Choline Alphoscerate on Behavioral Disturbances in Alzheimer’s Disease: Interim Results of the ASCOMALVA Trial

Article type: Research Article

Authors: Carotenuto, Anna^{a; b} | Rea, Raffaele^{a; b} | Traini, Enea^a | Fasanaro, Angiola Maria^b | Ricci, Giovanna^c | Manzo, Valentino^b | Amenta, Francesco^{a; *}

Affiliations: [a] Clinical Research, Telemedicine and Telepharmacy Center, University of Camerino, Camerino, Italy | [b] Neurology Unit, National Hospital, “A. Cardarelli”, Naples, Italy | [c] Bioethics and Legal Medicine Center, School of Law, University of Camerino, Camerino, Italy

Correspondence: [*] Correspondence to: Francesco Amenta, Centro Ricerche Cliniche, Telemedicina e Telefarmacia, Scuola di Scienze del Farmaco e dei Prodotti della Salute, Via Madonna delle Carceri, 9, 62032 Camerino, Italy. Tel.: +39 0737 403311; Fax: +39 0737 403325; E-mail: [email protected].

Abstract: Background: Behavioral and psychological symptoms of dementia (BPSD) are a group of psychological reactions, psychiatric symptoms, and behaviors commonly found in Alzheimer’s disease (AD). Four clusters of BPSD have been described: mood disorders (depression, anxiety, and apathy), psychotic symptoms (delusions and hallucinations), aberrant motor behaviors (pacing, wandering, and other purposeless behaviors), and inappropriate behaviors (agitation, disinhibition, and euphoria). Most of them are attributed to acetylcholine deficiency. Objective: To evaluate if a higher amount of acetylcholine obtained by associating donepezil and choline alphoscerate might have a favorable effect on BPSD. Methods: BPSD were measured at baseline and after 24 months in 113 mild/moderate AD patients, included in the double-blind randomized trial ASCOMALVA, by the Neuropsychiatric Inventory (NPI). Two matched groups were compared: group A treated with donepezil (10 mg/day) plus choline alphoscerate (1200 mg/day), and group B treated with donepezil (10 mg/day) plus placebo. Results: Data of NPI revealed a significant decrease of BPSD severity and distress of the caregiver in patients of group A compared with group B. Mood disorders (depression, anxiety and apathy) were significantly decreased in subjects treated with donepezil and choline alphoscerate, while their severity and frequency was increased in the other group. Conclusions: Patients treated with donepezil plus choline alphoscerate showed a lower level of behavioral disturbances than subjects treated with donepezil only, suggesting that the association can have beneficial effects.

Keywords: Alzheimer’s disease, behavioral and psychological symptoms of dementia, choline alphoscerate, donepezil, neuropsychiatric symptoms

DOI: 10.3233/JAD-160675

Journal: Journal of Alzheimer's Disease, vol. 56, no. 2, pp. 805-815, 2017