Donepezil Significantly Improves Abilities in Daily Lives of Female down Syndrome Patients with Severe Cognitive Impairment: A 24-Week Randomized, Double-Blind, Placebo-Controlled Trial

2011 ◽  
Vol 41 (1) ◽  
pp. 71-89 ◽  
Author(s):  
Tatsuro Kondoh ◽  
Atsushi Kanno ◽  
Hiroshi Itoh ◽  
Mikiro Nakashima ◽  
Ryoko Honda ◽  
...  

Objective: Down syndrome (DS) patients share certain neuropathological features with Alzheimer disease patients. A randomized, double-blind, placebo-controlled study was performed to investigate the efficacy and safety of donepezil, an Alzheimer disease drug, for DS patients. Method: Twenty-one DS patients with severe cognitive impairment were assigned to take donepezil (3 mg daily) or a placebo for 24 weeks, and evaluated for activities in daily lives by concisely modified International Classification of Functioning, Disability and Health (ICF) scaling system. Results: ICF scores significantly increased without any adverse effects in the donepezil group in comparison to those in the placebo control. Among the individual functions tested, there was a dramatic improvement in the global mental functions and in specific mental functions. Conclusions: Donepezil may effectively and safely improve overall functioning of DS patients with severe cognitive impairment.

2013 ◽  
Vol 10 (7) ◽  
pp. 742-753 ◽  
Author(s):  
Joel Ross ◽  
Sanjiv Sharma ◽  
Jaron Winston ◽  
Margarita Nunez ◽  
Gabriella Bottini ◽  
...  

1997 ◽  
Vol 150 ◽  
pp. S296
Author(s):  
L. Sabe ◽  
G. Kuzis ◽  
A. García Cuerva ◽  
C. Tiberti ◽  
M.F. Dorrego ◽  
...  

2005 ◽  
Vol 39 (3) ◽  
pp. 563-566 ◽  
Author(s):  
Tatsuro Kondoh ◽  
Nagisa Amamoto ◽  
Tomoki Doi ◽  
Hitomi Hamada ◽  
Yoji Ogawa ◽  
...  

OBJECTIVE: To report 2 cases of patients with Down syndrome and severe cognitive impairment who gained dramatic improvements in quality of life (QOL) upon donepezil treatment. CASE SUMMARIES: Case 1. A 38-year-old woman with Down syndrome, diagnosed with secondary progressive dementia when her mental state had deteriorated rapidly after graduation from junior high school, started donepezil treatment. The loading dose was 3 mg/day and was increased to 5 mg/day for maintenance. One month after the dose was increased, adverse effects such as soft stool and urinary incontinence appeared. These adverse effects disappeared when the dose was decreased again to 3 mg/day. Her QOL improved dramatically with this minimal dose. She recovered verbal and written communication skills that she had lost for the past 21 years. Case 2. A 22-year-old man with Down syndrome, who had been diagnosed as having severe mental retardation, was put on donepezil therapy. Both loading and maintenance doses were 3 mg/day. His QOL had also dramatically improved, with some recovery in verbal communication. Transient agitation/violence and transient muscle weakness appeared during the first few months of treatment. DISCUSSION: Patients with Down syndrome may be more sensitive to donepezil therapy than others and may benefit from this medicine, although they may also have adverse effects more frequently. CONCLUSIONS: Donepezil may be a useful medicine for some patients with Down syndrome with severe cognitive impairment or mental retardation if the adverse effects are manageable.


Neurology ◽  
2007 ◽  
Vol 69 (Issue 4, Supplement 1) ◽  
pp. S14-S22 ◽  
Author(s):  
B. Winblad ◽  
G. Grossberg ◽  
L. Frolich ◽  
M. Farlow ◽  
S. Zechner ◽  
...  

2017 ◽  
Vol 7 (1) ◽  
pp. 136-142 ◽  
Author(s):  
Hossein Pakdaman ◽  
Ali Amini Harandi ◽  
Mehdi Abbasi ◽  
Hosein Delavar Kasmaei ◽  
Farzad Ashrafi ◽  
...  

Background and Aim: Mild cognitive impairment (MCI) is characterized by declined cognitive function greater than that expected for a person’s age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients. Methods: Seventy-two patients with a diagnosis of MCI were recruited. The included participants were randomly assigned to groups to receive either MLC601 or placebo. An evaluation of global cognitive function was performed at baseline as well as at 3-month and 6-month follow-up visits. Global cognitive function was assessed by Mini-Mental State Examination (MMSE) and Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) scores. Efficacy was evaluated by comparing global function scores between the 2 groups during the study period. Safety assessment included adverse events (AEs) and abnormal laboratory results. Results: Seventy patients completed the study, 34 in the MLC601 group and 36 in the placebo group. The mean changes (±SD) in cognition scores over 6 months in the MLC601 group were –2.26 (±3.42) for the MMSE and 3.82 (±6.16) for the ADAS-cog; in the placebo group, they were –2.66 (±3.43) for the MMSE and 4.41 (±6.66) for the ADAS-cog. The cognition changes based on both MMSE and ADAS-cog scores were statistically significant between the placebo and the MLC601 group (p < 0.001). Only 5 patients (14.7%) reported minor AEs in the MLC601 group, the most commonly reported of which were gastrointestinal, none of them leading to patient withdrawal. Conclusion: MLC601 has shown promising efficacy and acceptable AEs in MCI patients.


SLEEP ◽  
2006 ◽  
Vol 29 (2) ◽  
pp. 199-205 ◽  
Author(s):  
Walter André dos Santos Moraes ◽  
Dalva Rollemberg Poyares ◽  
Christian Guilleminault ◽  
Luiz Roberto Ramos ◽  
Paulo Henrique Ferreira Bertolucci ◽  
...  

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