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Meta-Analysis
. 2012 Mar 14;2012(3):CD006504.
doi: 10.1002/14651858.CD006504.pub2.

Cholinesterase inhibitors for dementia with Lewy bodies, Parkinson's disease dementia and cognitive impairment in Parkinson's disease

Michal Rolinski  1 , Chris Fox, Ian Maidment, Rupert McShane
Affiliations
Meta-Analysis

Cholinesterase inhibitors for dementia with Lewy bodies, Parkinson's disease dementia and cognitive impairment in Parkinson's disease

Michal Rolinski et al. Cochrane Database Syst Rev. .

Abstract

Background: Previous Cochrane reviews have considered the use of cholinesterase inhibitors in both Parkinson's disease with dementia (PDD) and dementia with Lewy bodies (DLB). The clinical features of DLB and PDD have much in common and are distinguished primarily on the basis of whether or not parkinsonism precedes dementia by more than a year. Patients with both conditions have particularly severe deficits in cortical levels of the neurotransmitter acetylcholine. Therefore, blocking its breakdown using cholinesterase inhibitors may lead to clinical improvement.

Objectives: To assess the efficacy, safety and tolerability of cholinesterase inhibitors in dementia with Lewy bodies (DLB), Parkinson's disease with dementia (PDD), and cognitive impairment in Parkinson's disease falling short of dementia (CIND-PD) (considered as separate phenomena and also grouped together as Lewy body disease).

Search methods: The trials were identified from a search of ALOIS, the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group (on 30 August 2011) using the search terms Lewy, Parkinson, PDD, DLB, LBD. This register consists of records from major healthcare databases (MEDLINE, EMBASE, PsycINFO, CINAHL) and many ongoing trial databases and is updated regularly.Reference lists of relevant studies were searched for additional trials.

Selection criteria: Randomised, double-blind, placebo-controlled trials assessing the efficacy of treatment with cholinesterase inhibitors in DLB, PDD and cognitive impairment in Parkinson's disease (CIND-PD).

Data collection and analysis: Data were extracted from published reports by one review author (MR). The data for each 'condition' (that is DLB, PDD or CIND-PD) were considered separately and, where possible, also pooled together. Statistical analysis was conducted using Review Manager version 5.0.

Main results: Six trials met the inclusion criteria for this review, in which a total of 1236 participants were randomised. Four of the trials were of a parallel group design and two cross-over trials were included. Four of the trials included participants with a diagnosis of Parkinson's disease with dementia (Aarsland 2002a; Dubois 2007; Emre 2004; Ravina 2005), of which Dubois 2007 remains unpublished. Leroi 2004 included patients with cognitive impairment and Parkinson's disease (both with and without dementia). Patients with dementia with Lewy bodies (DLB) were included in only one of the trials (McKeith 2000).For global assessment, three trials comparing cholinesterase inhibitor treatment to placebo in PDD (Aarsland 2002a; Emre 2004; Ravina 2005) reported a difference in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) score of -0.38, favouring the cholinesterase inhibitors (95% CI -0.56 to -0.24, P < 0.0001).For cognitive function, a pooled estimate of the effect of cholinesterase inhibitors on cognitive function measures was consistent with the presence of a therapeutic benefit (standardised mean difference (SMD) -0.34, 95% CI -0.46 to -0.23, P < 0.00001). There was evidence of a positive effect of cholinesterase inhibitors on the Mini-Mental State Examination (MMSE) in patients with PDD (WMD 1.09, 95% CI 0.45 to 1.73, P = 0.0008) and in the single PDD and CIND-PD trial (WMD 1.05, 95% CI 0.42 to 1.68, P = 0.01) but not in the single DLB trial.For behavioural disturbance, analysis of the pooled continuous data relating to behavioural disturbance rating scales favoured treatment with cholinesterase inhibitors (SMD -0.20, 95% CI -0.36 to -0.04, P = 0.01).For activities of daily living, combined data for the ADCS and the Unified Parkinson's Disease Rating Scale (UPDRS) activities of daily living rating scales favoured treatment with cholinesterase inhibitors (SMD -0.20, 95% CI -0.38 to -0.02, P = 0.03).For safety and tolerability, those taking a cholinesterase inhibitor were more likely to experience an adverse event (318/452 versus 668/842; odds ratio (OR) 1.64, 95% CI 1.26 to 2.15, P = 0.0003) and to drop out (128/465 versus 45/279; OR 1.94, 95% CI 1.33 to 2.84, P = 0.0006). Adverse events were more common amongst those taking rivastigmine (357/421 versus 173/240; OR 2.28, 95% CI 1.53 to 3.38, P < 0.0001) but not those taking donepezil (311/421 versus 145/212; OR 1.24, 95% CI 0.86 to 1.80, P = 0.25). Parkinsonian symptoms in particular tremor (64/739 versus 12/352; OR 2.71, 95% CI 1.44 to 5.09, P = 0.002), but not falls (P = 0.39), were reported more commonly in the treatment group but this did not have a significant impact on the UPDRS (total and motor) scores (P = 0.71). Fewer deaths occurred in the treatment group than in the placebo group (4/465 versus 9/279; OR 0.28, 95% CI 0.09 to 0.84, P = 0.03).

Authors' conclusions: The currently available evidence supports the use of cholinesterase inhibitors in patients with PDD, with a positive impact on global assessment, cognitive function, behavioural disturbance and activities of daily living rating scales. The effect in DLB remains unclear. There is no current disaggregated evidence to support their use in CIND-PD.

PubMed Disclaimer

Conflict of interest statement

RMcS has received financial support to attend conferences from Eisai, Shire and Novartis, all marketers of cholinesterase inhibitors, more than five years ago. Within the last two years, his institution has received funding for his activities as a local PL for a Novartis study of rivastigmine patch versus tablets in Parkinson's disease dementia.

Figures

1
1
Forest plot of comparison: 1 Global assessment, outcome: 1.1 Alzheimer's Disease Cooperative Study ‐ Clinician's Global Impression of Change (ADCS‐CGIC).
2
2
Forest plot of comparison: 2 Cognitive function, outcome: 2.3 Combined: MMSE or ADASCog.
3
3
Forest plot of comparison: 3 Behavioural disturbance, outcome: 3.5 Combined.
4
4
Forest plot of comparison: 5 Safety and tolerability, outcome: 5.9 Unified Parkinson's Disease Rating Scale (UPDRS).
1.1
1.1. Analysis
Comparison 1 Global assessment, Outcome 1 Alzheimer's Disease Cooperative Study ‐ Clinician's Global Impression of Change (ADCS‐CGIC).
1.2
1.2. Analysis
Comparison 1 Global assessment, Outcome 2 Clinical Global Responder ‐ at least minimal improvement.
2.1
2.1. Analysis
Comparison 2 Cognitive function, Outcome 1 Mini Mental State Examination.
2.2
2.2. Analysis
Comparison 2 Cognitive function, Outcome 2 Alzheimer's Disease Assessment Scale (ADAS‐cog).
2.3
2.3. Analysis
Comparison 2 Cognitive function, Outcome 3 Combined: MMSE or ADASCog.
2.4
2.4. Analysis
Comparison 2 Cognitive function, Outcome 4 Mattis Dementia Rating Scale (MDRS).
2.5
2.5. Analysis
Comparison 2 Cognitive function, Outcome 5 Cognitive Drug Research (CDR) computerised assessment system power of attention.
2.6
2.6. Analysis
Comparison 2 Cognitive function, Outcome 6 Delis‐Kaplan Executive Function System (D‐KEFS).
2.7
2.7. Analysis
Comparison 2 Cognitive function, Outcome 7 Ten Point Clock Drawing Test.
2.8
2.8. Analysis
Comparison 2 Cognitive function, Outcome 8 Brief Test of Attention (BTA).
2.9
2.9. Analysis
Comparison 2 Cognitive function, Outcome 9 Trail Making Test (TMT) A.
2.10
2.10. Analysis
Comparison 2 Cognitive function, Outcome 10 Trail Making Test (TMT) B.
2.11
2.11. Analysis
Comparison 2 Cognitive function, Outcome 11 Verbal Fluency Test.
2.12
2.12. Analysis
Comparison 2 Cognitive function, Outcome 12 Hopkins Verbal Learning Test.
2.13
2.13. Analysis
Comparison 2 Cognitive function, Outcome 13 Developmental Test of Visual‐Motor Integration (VMI).
3.1
3.1. Analysis
Comparison 3 Behavioural disturbance, Outcome 1 12‐item Neuropsychiatric Inventory (NPI‐12).
3.2
3.2. Analysis
Comparison 3 Behavioural disturbance, Outcome 2 10‐item Neuropsychiatric Inventory (NPI‐10).
3.3
3.3. Analysis
Comparison 3 Behavioural disturbance, Outcome 3 4‐item Neuropsychiatric Inventory (NPI‐4).
3.4
3.4. Analysis
Comparison 3 Behavioural disturbance, Outcome 4 Brief Psychiatric Rating Scale.
3.5
3.5. Analysis
Comparison 3 Behavioural disturbance, Outcome 5 Combined.
4.1
4.1. Analysis
Comparison 4 Activities of daily living, Outcome 1 Alzheimer's Disease Cooperative Study ‐ Activities of Daily Living (ADCS‐ADL).
4.2
4.2. Analysis
Comparison 4 Activities of daily living, Outcome 2 Unified Parkinson's Disease Rating Scale (UPDRS) ‐ Activities of Daily Living.
4.3
4.3. Analysis
Comparison 4 Activities of daily living, Outcome 3 Combined.
5.1
5.1. Analysis
Comparison 5 Safety and tolerability, Outcome 1 Dropouts.
5.2
5.2. Analysis
Comparison 5 Safety and tolerability, Outcome 2 Dropouts due to Adverse Events.
5.3
5.3. Analysis
Comparison 5 Safety and tolerability, Outcome 3 Adverse Events.
5.4
5.4. Analysis
Comparison 5 Safety and tolerability, Outcome 4 Severe Adverse Events.
5.5
5.5. Analysis
Comparison 5 Safety and tolerability, Outcome 5 Parkinsonian symptoms reported as adverse effects.
5.6
5.6. Analysis
Comparison 5 Safety and tolerability, Outcome 6 Tremor.
5.7
5.7. Analysis
Comparison 5 Safety and tolerability, Outcome 7 Falls.
5.8
5.8. Analysis
Comparison 5 Safety and tolerability, Outcome 8 Hallucinations.
5.9
5.9. Analysis
Comparison 5 Safety and tolerability, Outcome 9 Unified Parkinson's Disease Rating Scale (UPDRS).
5.10
5.10. Analysis
Comparison 5 Safety and tolerability, Outcome 10 Deaths.
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