Donepezil for dementia with Lewy bodies: A randomized, placebo-controlled, confirmatory phase III trial

Alzheimer's Research and Therapy

Volumn 7, Issue 1, 2015, Pages

  Ikeda, Manabu ^a   Mori, Etsuro ^b   Matsuo, Kazutaka ^c   Nakagawa, Masaki ^c   Kosaka, Kenji ^d  

^a KUMAMOTO UNIVERSITY   (Japan)

^b TOHOKU UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c EISAI CO LTD   (Japan)

^d YOKOHAMA CITY UNIVERSITY   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

DONEPEZIL;

AGED; ARTICLE; CAREGIVER BURDEN; COGNITION; CONTROLLED STUDY; CONTUSION; DECREASED APPETITE; DIFFUSE LEWY BODY DISEASE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECG ABNORMALITY; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; HALLUCINATION; HEART VENTRICLE EXTRASYSTOLE; HUMAN; HYPOTENSION; INCIDENCE; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MINI MENTAL STATE EXAMINATION; NAUSEA; NEUROPSYCHIATRIC INVENTORY 2; NEUROPSYCHOLOGICAL TEST; PARANOIA; PARKINSONISM; PHASE 3 CLINICAL TRIAL; POLLAKISURIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SYMPTOMATOLOGY; UNIFIED PARKINSON DISEASE RATING SCALE; VISUAL HALLUCINATION;

EID: 84925854219     PISSN: None     EISSN: 17589193     Source Type: Journal    
DOI: 10.1186/s13195-014-0083-0     Document Type: Article

References (31)

1. McKeith I, Mintzer J, Aarsland D, Burn D, Chiu H, Cohen-Mansfield J, Dickson D, Dubois B, Duda JE, Feldman H, Gauthier S, Halliday G, Lawlor B, Lippa C, Lopez OL, Carlos MJ, O'Brien J, Playfer J, Reid W, International Psychogeriatric Association Expert Meeting on DLB: Dementia with Lewy bodies. Lancet Neurol 2004, 3:19-28.
2. McKeith IG, Galasko D, Kosaka K, Perry EK, Dickson DW, Hansen LA, Salmon DP, Lowe J, Mirra SS, Byrne EJ, Lennox G, Quinn NP, Edwardson JA, Ince PG, Bergeron C, Burns A, Miller BL, Lovestone S, Collerton D, Jansen EN, Ballard C, de Vos RA, Wilcock GK, Jellinger KA, Perry RH: Consensus guidelines for the clinical and pathologic diagnosis of dementia with Lewy bodies (DLB): report of the consortium on DLB international workshop. Neurology 1996, 47:1113-1124.
3. Allan L, McKeith I, Ballard C, Kenny RA: The prevalence of autonomic symptoms in dementia and their association with physical activity, activities of daily living and quality of life. Dement Geriatr Cogn Disord 2006, 22:230-237.
4. McKeith IG, Rowan E, Askew K, Naidu A, Allan L, Barnett N, Lett D, Mosimann UP, Burn D, O'Brien JT: More severe functional impairment in dementia with lewy bodies than Alzheimer disease is related to extrapyramidal motor dysfunction. Am J Geriatr Psychiatry 2006, 14:582-588.
5. Lippa CF, Smith TW, Perry E: Dementia with Lewy bodies: choline acetyltransferase parallels nucleus basalis pathology. J Neural Transm 1999, 106:525-535.
6. Perry EK, Haroutunian V, Davis KL, Levy R, Lantos P, Eagger S, Honavar M, Dean A, Griffiths M, McKeith IG, Perry RH: Neocortical cholinergic activities differentiate Lewy body dementia from classical Alzheimer's disease. Neuroreport 1994, 5:747-749.
7. Perry EK, Irving D, Kerwin JM, McKeith IG, Thompson P, Collerton D, Fairbairn AF, Ince PG, Morris CM, Cheng AV, Perry RH: Cholinergic transmitter and neurotrophic activities in Lewy body dementia: similarity to Parkinson's and distinction from Alzheimer disease. Alzheimer Dis Assoc Disord 1993, 7:69-79.
8. Ballard C, Piggott M, Johnson M, Cairns N, Perry R, McKeith I, Jaros E, O'Brien J, Holmes C, Perry E: Delusions associated with elevated muscarinic binding in dementia with Lewy bodies. Ann Neurol 2000, 48:868-876.
9. McKeith IG, Dickson DW, Lowe J, Emre M, O'Brien JT, Feldman H, Cummings J, Duda JE, Lippa C, Perry EK, Aarsland D, Arai H, Ballard CG, Boeve B, Burn DJ, Costa D, Del Ser T, Dubois B, Galasko D, Gauthier S, Goetz CG, Gomez-Tortosa E, Halliday G, Hansen LA, Hardy J, Iwatsubo T, Kalaria RN, Kaufer D, Kenny RA, Korczyn A, et al: Diagnosis and management of dementia with Lewy bodies: third report of the DLB Consortium. Neurology 2005, 65:1863-1872.
10. O'Brien JT, Burns A, BAP Dementia Consensus Group: Clinical practice with anti-dementia drugs: a revised (second) consensus statement from the British Association for Psychopharmacology. J Psychopharmacol 2011, 25:997-1019.
11. Mori E, Ikeda M, Kosaka K, Donepezil-DLB Study Investigators: Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled trial. Ann Neurol 2012, 72:41-52.
12. Ikeda M, Mori E, Kosaka K, Iseki E, Hashimoto M, Matsukawa N, Matsuo K, Nakagawa M, Donepezil-DLB Study Investigators: Long-term safety and efficacy of donepezil in patients with dementia with Lewy bodies: results from a 52-week, open-label, multicenter extension study. Dement Geriatr Cogn Disord 2013, 36:229-241.
13. Mori E, Ikeda M, Nagai R, Matsuo K, Nakagawa M, Kosaka K: Long-term donepezil use for dementia with Lewy bodies: results from an open-label extension of phase III trial. Alzheimers Res Ther, DOI 10.1186/s13195-014-0081-2.
14. Cummings JL: The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology 1997, 48:S10-S16.
15. Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J: The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology 1994, 44:2308-2314.
16. Hashimoto M, Manabe Y, Mori E, Hirono N, Kosaka K, Ikeda M: Content validity and inter-rater reliability of the Cognitive Fluctuation Inventory [Article in Japanese]. Brain Nerve 2014, 66:175-183.
17. Mori S, Mori E, Iseki E, Kosaka K: Efficacy and safety of donepezil in patients with dementia with Lewy bodies: preliminary findings from an open-label study. Psychiatry Clin Neurosci 2006, 60:190-195.
18. Hoehn MM, Yahr MD: Parkinsonism: onset, progression and mortality. Neurology 1967, 17:427-442.
19. Folstein MF, Folstein SE, McHugh PR: "Mini-Mental State": a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975, 12:189-198.
20. Zarit SH, Reever KE, Bach-Peterson J: Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist 1980, 20:649-655.
21. Fahn S, Elton R, UPDRS Development Committee: Unified Parkinson's Disease Rating Scale. In Recent Developments in Parkinson's Disease. Volume 2. Edited by Fahn S, Marsden CD, Calne DB, Goldstein M. New York: Macmillan Healthcare Information; 1987:153-163. 293-304.
22. Rogers SL, Doody RS, Mohs RC, Friedhoff LT: Donepezil improves cognition and global function in Alzheimer disease: a 15-week, double-blind, placebo-controlled study. Donepezil Study Group Arch Intern Med 1998, 158:1021-1031.
23. Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT, the Donepezil Study Group: A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Neurology 1998, 50:136-145.
24. Ota K, Iseki E, Murayama N, Fujishiro H, Kasanuki K, Chiba Y, Sato K, Arai H: Psychosocial risk factors for clinical symptoms in patients with dementia with Lewy bodies compared with Alzheimer's disease [Article in Japanese]. Jpn J Geriatr Psychiatry 2012, 23:457-465.
25. Ota K, Iseki E, Murayama N, Fujishiro H, Arai H, Sato K: Effect of psychological intervention for visual hallucinations in patients with dementia with Lewy bodies. Clin Psychiatry 2011, 53:845-853.
26. Cummings J, Isaacson S, Mills R, Williams H, Chi-Burris K, Corbett A, Dhall R, Ballard C: Pimavanserin for patients with Parkinson's disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet 2013, 383:533-540.
27. Olichney JM, Galasko D, Salmon DP, Hofstetter CR, Hansen LA, Katzman R, Thal LJ: Cognitive decline is faster in Lewy body variant than in Alzheimer's disease. Neurology 1998, 51:351-357.
28. Bostrom F, Jonsson L, Minthon L, Londos E: Patients with dementia with Lewy bodies have more impaired quality of life than patients with Alzheimer disease. Alzheimer Dis Assoc Disord 2007, 21:150-154.
29. Lee DR, McKeith I, Mosimann U, Ghosh-Nodyal A, Thomas AJ: Examining carer stress in dementia: the role of subtype diagnosis and neuropsychiatric symptoms. Int J Geriatr Psychiatry 2013, 28:135-141.
30. Rongve A, Vossius C, Nore S, Testad I, Aarsland D: Time until nursing home admission in people with mild dementia: comparison of dementia with Lewy bodies and Alzheimer's dementia. Int J Geriatr Psychiatry 2014, 29:392-398.
31. McKeith I, Del Ser T, Spano P, Emre M, Wesnes K, Anand R, Cicin-Sain A, Ferrara R, Spiegel R: Efficacy of rivastigmine in dementia with Lewy bodies: a randomised, double-blind, placebo-controlled international study. Lancet 2000, 356:2031-2036.