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  string(1624) "Background: Over 800,000 people suffer with dementia in the UK. The evidence base for the treatment of dementia is small. One reason for this may be that the measures used to assess cognition in clinical trials are not sensitive to change and/or the analyses used are suboptimal.
Objective: OA-Cog aims to identify the most efficient cognitive measurement and analysis method for cognition and dementia in randomised controlled trials including patients with or at risk of vascular dementia or Alzheimer?s disease.
Study Design: Chief investigators of randomised controlled trials with cognitive outcome assessments are asked to share individual patient data from their trials. Variables requested include baseline prognostic factors, treatment group, cognitive measures (e.g. Mini Mental State Examination (MMSE)) and other outcome measures (e.g. death, dementia).
Data from shared trials will be reanalysed using various statistical methods to identify which is most efficient.
Participants: Participants with or at risk of vascular dementia or Alzheimer?s disease will be included.
Main outcome measure: A number of global cognition outcomes will be analysed (e.g. MMSE).
Statistical analysis: Data will be analysed using various endpoints (e.g. mean MMSE score at end of trial, MMSE score as a gradient over time) and statistical methods (e.g. Wilcoxon rank-sum test, repeated measures ANOVA) in order to identify the most efficient. Approaches for dealing with missing data and in particular missing data due to death be addressed; currently, such patients are ignored from analyses." ["project_brief_bg"]=> string(691) "Over 800,000 people suffer with dementia in the UK [1]. Despite being common; costly in economic terms to society and devastating to patients and their families, the evidence base for the treatment of cognitive decline and dementia is small. One reason for this may be that the measures used to assess cognition in clinical trials are not sensitive to change and/or the analyses used are suboptimal. OA-Cog aims to assess this hypothesis.
Taking a commonly used global measure of cognition, the mini mental state examination (MMSE), several approaches for analysis of this outcome have been used in completed trials:
1. Comparison of proportions with cognitive decline, i.e. MMSE" ["project_specific_aims"]=> string(946) "? To identify the most efficient statistical analysis method for analysing global cognition data (e.g. MMSE, ADAS-Cog) and dementia from randomised controlled trials including patients with or at risk of vascular dementia or Alzheimer?s disease.
? To identify the most efficient cognitive measurement for use in randomised controlled trials including patients with or at risk of vascular dementia or Alzheimer?s disease, from a statistical perspective.
? To identify the most appropriate missing data technique for use with cognitive data from randomised controlled trials including patients with or at risk of vascular dementia or Alzheimer?s disease.
? To assess how patients who have died should be included in the analysis.
? To assess the implication of choosing particular methods of analysis on trial sample size
? To assess the implication of adjusting analyses for baseline prognostic factors on sample size" ["project_study_design"]=> string(0) "" ["project_study_design_exp"]=> string(0) "" ["project_purposes"]=> array(2) { [0]=> array(2) { ["value"]=> string(36) "Participant-level data meta-analysis" ["label"]=> string(36) "Participant-level data meta-analysis" } [1]=> array(2) { ["value"]=> string(69) "Meta-analysis using data from the YODA Project and other data sources" ["label"]=> string(69) "Meta-analysis using data from the YODA Project and other data sources" } } ["project_purposes_exp"]=> string(0) "" ["project_software_used"]=> string(0) "" ["project_software_used_exp"]=> string(0) "" ["project_research_methods"]=> string(550) "Eligible trials include randomised controlled trials in patients with or at risk of vascular dementia or Alzheimer?s disease with on treatment global cognition data. Trials of any intervention will be considered for the project. Trials included in the project will either be positive (i.e. showing statistical evidence of benefit), negative or from a meta-analysis showing statistically significant benefit or harm. There are no individual patient inclusion/exclusion criteria. Data from 32 other trials assessing cognition have been obtained so far." ["project_main_outcome_measure"]=> string(1140) "A number of outcomes will be analysed as the aim of the study is to identify the most efficient for the analysis of cognition in patients with or at risk of Alzheimer?s disease or Vascular dementia. Outcomes of interest to the study include:
Continuous outcomes:
? Mini-mental state examination (MMSE)
? Alzheimer?s disease assessment scale ? cognitive sub-score (ADAS-Cog)
? Montreal cognitive assessment (MoCA)
? Addenbrooke?s cognitive examination ? revised (ACE-R)
? Clinical Dementia Rating Sum of Boxes (CDR-SB)
? Trail making test
? Finger tapping test, new dot test and maze tracing test
? CDR and category fluency test
? Modified Boston naming test
? Raven?s coloured matrices
? Telephone interview for cognitive status
Ordinal outcomes:
? Ordinal cognition which combines impairment and dementia: normal score (MMSE>28) / mild impairment (MMSE 23 ? 28), moderate impairment (MMSE 10 ? 22) / severe impairment (MMSE < 10) / dementia
Binary outcomes:
? Dementia (yes, no) and time to diagnosis
? Death (yes, no) and time to death." ["project_main_predictor_indep"]=> string(253) "The main predictor variable will be randomisation allocation. Randomisation will be categorised as active versus control (as defined in each trial protocol). For factorial and partial factorial trials each comparison will be treated as a separate trial." ["project_other_variables_interest"]=> string(1053) "Other variables which Chief investigators of trials have been asked to share include:
Demographics and risk factors: age, sex, history of hypertension, smoking status, hypercholesterolemia, previous stroke, previous MI, diabetes mellitus, history of cognitive impairment, history of dementia, atrial fibrillation, education and family history of dementia.
Baseline clinical data: blood pressure, cholesterol, glucose, ECG, stroke type and severity (if applicable), global cognition scale (e.g. MMSE, ADAS-Cog) score, APOE ?4 carrier, mood/depression (yes/no or scale and score) and functional status (e.g. modified Rankin scale).
Trial characteristics: randomisation (active, control), randomisation date, start date of intervention, indication for trial (e.g. Alzheimer?s disease, mild cognitive impairment, stroke, hypertension) and length of follow up.
Other non-cognitive outcomes measures: functional outcome (e.g. modified Rankin scale), quality of life, mood/depression (yes/no or scale and score) and stroke during trial." ["project_stat_analysis_plan"]=> string(1047) "The following analyses will be performed on the MMSE at the end of the trial (?end of trial? is defined as the last visit post baseline where >80% of participants have a score or the post baseline with the highest percentage of non-missing data if no post baseline visits have data for >80% of participants):
1. Proportions with cognitive decline and dementia: chi-square test; binary logistic regression.
2. Binary cognition with only one cut off point (MMSE ?16 vs >16): chi-square test; binary logistic regression.
3. Mean score at end of treatment: two-sample t-test (parametric)
5. Median score at end of treatment: Wilcoxon (Mann-Whitney U) test (non-parametric)
6. Mean change in score from baseline: two-sample t-test
7. Gradient of score (needs score at multiple time points): repeated measures ANOVA
8. Ordinal cognition (5 level) which combines impairment and dementia: normal score (MMSE>28) / mild impairment (23 ? 28) / moderate impairment (10-22) / severe impairment (23) / impairment (MMSE" ["project_timeline"]=> string(346) "Data collection will continue until third quarter 2016. Coding of analyses has begun and will continue until second quarter 2017. Manuscripts will be written once coding and interpretation of analyses has been completed. Once draft manuscripts have been written, they will be sent to collaborators for comments and then submitted for publication." ["project_dissemination_plan"]=> string(955) "The results of analyses for individual trials will not be published (since the Collaborators have already done this); rather, the results of different analysis methods across the trials will be compared and published. As a result, individual trials will not be identifiable. The results will be published under the banner of OA-COG with the collaboration listed by name. Collaborators will be listed in the acknowledgments by trial. The papers will be written by a ?Publication Committee? which includes the Principal Investigator and the project statistician. Draft manuscripts will then distributed to all Collaborators (investigators who have shared data with the collaboration) for comment, interpretation, changes, additions etc. The results will be submitted to major dementia conference(s) for presentation, and submitted for publication in major quality peer-reviewed journal(s). Data will not be used for any purpose other than to do with OA-COG." ["project_bibliography"]=> string(2270) "

[1] Prince, M. et al., Dementia UK: – overview. 2014.
[2] Tzourio, C., et al., Effects of blood pressure lowering with perindopril and indapamide therapy on dementia and cognitive decline in patients with cerebrovascular disease. Arch Intern Med, 2003. 163(9): p. 1069-75.
[3] Heart Protection Study Collaborative Group, MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20536 high-risk individuals: a randomised placebo-controlled trial. Lancet, 2002. 360: p. 7-22.
[4] Prince, M.J., et al., Is the cognitive function of older patients affected by antihypertensive treatment? Reuslts from 54 months of the Medical Research Council’s treatment trial of hypertension in older adults. British Medical Journal, 1996. 312: p. 801-5.
[5] Simons, M., et al., Treatment with simvastatin in normocholesterolemic patients with Alzheimer’s disease: A 26-week randomized, placebo-controlled, double-blind trial. Ann Neurol, 2002. 52: p. 346-350.
[6] Sparks, D.L., et al., Atorvastatin for the treatment of mild to moderate Alzheimer disease. Arch Neurol, 2005. 62: p. 753-757.
[7] Applegate, W.B., et al., Impact of the treatment of isolated systolic hypertension on behavioral variables. Arch Intern Med, 1994. 154.
[8] Skoog, I., et al., Effect of baseline cognitive function and antihypertensive treatment on cognitive and cardiovascular outcomes: study on COgnition and Prognosis in the Elderly (SCOPE). American Journal of Hypertension, 2005. 18: p. 1052-59.
[9] Shepherd, J., et al., Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet, 2002. 360: p. 1623-1630.
[10] Muldoon, M.F., et al., Randomized trial of the effects of simvastatin on cognitive functioning in hypercholesterolemic adults. The American Journal of Medicine, 2004. 117(11): p. 823-9.
[11] Wardlaw, J.M., et al., Thrombolysis for acute ischaemic stroke. Cochrane Database Systematic Review, 2003(3).
[12] Di Bari, M., et al., Dementia and disability outcomes in large hypertension trials: lessons learned from the systolic hypertension in the elderly program (SHEP) trial. American Journal of Epidemiology, 2001. 153(1): p. 72-78.

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2016-0765

General Information

How did you learn about the YODA Project?: Data Holder (Company)

Conflict of Interest

Request Clinical Trials

Associated Trial(s):
  1. NCT00253201 - Efficacy, Tolerability and Safety of Galantamine in the Treatment of Alzheimer's Disease
  2. NCT00304629 - Long Term Safety and Efficacy of Galantamine in Alzheimer's Disease (Extension INT-8)
  3. NCT00253227 - Galantamine in the Treatment of Alzheimer's Disease: Flexible Dose Range Trial
  4. Long Term Safety and Efficacy of Galantamine in the treatment of Alzheimer's Disease
  5. NCT00261573 - The Safety and Efficacy of Galantamine in the Treatment of Vascular and Mixed Dementia
  6. NCT00253188 - Efficacy, Tolerability and Safety of Galantamine in the Treatment of Alzheimer's Disease
  7. NCT00253214 - Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy of a Controlled-Release Formulation
  8. NCT00236574 - A Randomized Double Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment (MCI) Clinically at Risk for Development of Clinically Probable Alzheimer's Disease
  9. NCT00236431 - A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment (MCI) Clinically at Risk for Development of Clinically Probable Alzheimer's Disease
  10. A long-term comparison of galantamine and donepezil in the treatment of Alzheimer's disease
  11. Galantamine treatment of vascular dementia: a randomized trial
What type of data are you looking for?:

Request Clinical Trials

Data Request Status

Status: Unknown - Revoked

Research Proposal

Project Title: Improving the statistical analysis of cognitive outcomes in randomised controlled trials: The ?Optimising the Analysis of Cognition? Collaboration

Scientific Abstract: Background: Over 800,000 people suffer with dementia in the UK. The evidence base for the treatment of dementia is small. One reason for this may be that the measures used to assess cognition in clinical trials are not sensitive to change and/or the analyses used are suboptimal.
Objective: OA-Cog aims to identify the most efficient cognitive measurement and analysis method for cognition and dementia in randomised controlled trials including patients with or at risk of vascular dementia or Alzheimer?s disease.
Study Design: Chief investigators of randomised controlled trials with cognitive outcome assessments are asked to share individual patient data from their trials. Variables requested include baseline prognostic factors, treatment group, cognitive measures (e.g. Mini Mental State Examination (MMSE)) and other outcome measures (e.g. death, dementia).
Data from shared trials will be reanalysed using various statistical methods to identify which is most efficient.
Participants: Participants with or at risk of vascular dementia or Alzheimer?s disease will be included.
Main outcome measure: A number of global cognition outcomes will be analysed (e.g. MMSE).
Statistical analysis: Data will be analysed using various endpoints (e.g. mean MMSE score at end of trial, MMSE score as a gradient over time) and statistical methods (e.g. Wilcoxon rank-sum test, repeated measures ANOVA) in order to identify the most efficient. Approaches for dealing with missing data and in particular missing data due to death be addressed; currently, such patients are ignored from analyses.

Brief Project Background and Statement of Project Significance: Over 800,000 people suffer with dementia in the UK [1]. Despite being common; costly in economic terms to society and devastating to patients and their families, the evidence base for the treatment of cognitive decline and dementia is small. One reason for this may be that the measures used to assess cognition in clinical trials are not sensitive to change and/or the analyses used are suboptimal. OA-Cog aims to assess this hypothesis.
Taking a commonly used global measure of cognition, the mini mental state examination (MMSE), several approaches for analysis of this outcome have been used in completed trials:
1. Comparison of proportions with cognitive decline, i.e. MMSE

Specific Aims of the Project: ? To identify the most efficient statistical analysis method for analysing global cognition data (e.g. MMSE, ADAS-Cog) and dementia from randomised controlled trials including patients with or at risk of vascular dementia or Alzheimer?s disease.
? To identify the most efficient cognitive measurement for use in randomised controlled trials including patients with or at risk of vascular dementia or Alzheimer?s disease, from a statistical perspective.
? To identify the most appropriate missing data technique for use with cognitive data from randomised controlled trials including patients with or at risk of vascular dementia or Alzheimer?s disease.
? To assess how patients who have died should be included in the analysis.
? To assess the implication of choosing particular methods of analysis on trial sample size
? To assess the implication of adjusting analyses for baseline prognostic factors on sample size

Study Design:

What is the purpose of the analysis being proposed? Please select all that apply.: Participant-level data meta-analysis Meta-analysis using data from the YODA Project and other data sources

Software Used:

Data Source and Inclusion/Exclusion Criteria to be used to define the patient sample for your study: Eligible trials include randomised controlled trials in patients with or at risk of vascular dementia or Alzheimer?s disease with on treatment global cognition data. Trials of any intervention will be considered for the project. Trials included in the project will either be positive (i.e. showing statistical evidence of benefit), negative or from a meta-analysis showing statistically significant benefit or harm. There are no individual patient inclusion/exclusion criteria. Data from 32 other trials assessing cognition have been obtained so far.

Primary and Secondary Outcome Measure(s) and how they will be categorized/defined for your study: A number of outcomes will be analysed as the aim of the study is to identify the most efficient for the analysis of cognition in patients with or at risk of Alzheimer?s disease or Vascular dementia. Outcomes of interest to the study include:
Continuous outcomes:
? Mini-mental state examination (MMSE)
? Alzheimer?s disease assessment scale ? cognitive sub-score (ADAS-Cog)
? Montreal cognitive assessment (MoCA)
? Addenbrooke?s cognitive examination ? revised (ACE-R)
? Clinical Dementia Rating Sum of Boxes (CDR-SB)
? Trail making test
? Finger tapping test, new dot test and maze tracing test
? CDR and category fluency test
? Modified Boston naming test
? Raven?s coloured matrices
? Telephone interview for cognitive status
Ordinal outcomes:
? Ordinal cognition which combines impairment and dementia: normal score (MMSE>28) / mild impairment (MMSE 23 ? 28), moderate impairment (MMSE 10 ? 22) / severe impairment (MMSE < 10) / dementia
Binary outcomes:
? Dementia (yes, no) and time to diagnosis
? Death (yes, no) and time to death.

Main Predictor/Independent Variable and how it will be categorized/defined for your study: The main predictor variable will be randomisation allocation. Randomisation will be categorised as active versus control (as defined in each trial protocol). For factorial and partial factorial trials each comparison will be treated as a separate trial.

Other Variables of Interest that will be used in your analysis and how they will be categorized/defined for your study: Other variables which Chief investigators of trials have been asked to share include:
Demographics and risk factors: age, sex, history of hypertension, smoking status, hypercholesterolemia, previous stroke, previous MI, diabetes mellitus, history of cognitive impairment, history of dementia, atrial fibrillation, education and family history of dementia.
Baseline clinical data: blood pressure, cholesterol, glucose, ECG, stroke type and severity (if applicable), global cognition scale (e.g. MMSE, ADAS-Cog) score, APOE ?4 carrier, mood/depression (yes/no or scale and score) and functional status (e.g. modified Rankin scale).
Trial characteristics: randomisation (active, control), randomisation date, start date of intervention, indication for trial (e.g. Alzheimer?s disease, mild cognitive impairment, stroke, hypertension) and length of follow up.
Other non-cognitive outcomes measures: functional outcome (e.g. modified Rankin scale), quality of life, mood/depression (yes/no or scale and score) and stroke during trial.

Statistical Analysis Plan: The following analyses will be performed on the MMSE at the end of the trial (?end of trial? is defined as the last visit post baseline where >80% of participants have a score or the post baseline with the highest percentage of non-missing data if no post baseline visits have data for >80% of participants):
1. Proportions with cognitive decline and dementia: chi-square test; binary logistic regression.
2. Binary cognition with only one cut off point (MMSE ?16 vs >16): chi-square test; binary logistic regression.
3. Mean score at end of treatment: two-sample t-test (parametric)
5. Median score at end of treatment: Wilcoxon (Mann-Whitney U) test (non-parametric)
6. Mean change in score from baseline: two-sample t-test
7. Gradient of score (needs score at multiple time points): repeated measures ANOVA
8. Ordinal cognition (5 level) which combines impairment and dementia: normal score (MMSE>28) / mild impairment (23 ? 28) / moderate impairment (10-22) / severe impairment (23) / impairment (MMSE

Narrative Summary: Over 800,000 people suffer with dementia in the UK. Despite being common; costly in economic terms and devastating to patients and their families, the evidence base for the treatment of dementia is small. This may be because statistical analyses used are suboptimal. OA-Cog aims to identify the most efficient analysis technique for cognition outcome data and dementia in randomised controlled trials. Chief investigators of RCTs with cognitive outcome date are asked to share their individual patient data. Data are then analysed using various statistical methods in order to identify which test produces the lowest p-value. Approaches for dealing with patients who die will also be addressed.

Project Timeline: Data collection will continue until third quarter 2016. Coding of analyses has begun and will continue until second quarter 2017. Manuscripts will be written once coding and interpretation of analyses has been completed. Once draft manuscripts have been written, they will be sent to collaborators for comments and then submitted for publication.

Dissemination Plan: The results of analyses for individual trials will not be published (since the Collaborators have already done this); rather, the results of different analysis methods across the trials will be compared and published. As a result, individual trials will not be identifiable. The results will be published under the banner of OA-COG with the collaboration listed by name. Collaborators will be listed in the acknowledgments by trial. The papers will be written by a ?Publication Committee? which includes the Principal Investigator and the project statistician. Draft manuscripts will then distributed to all Collaborators (investigators who have shared data with the collaboration) for comment, interpretation, changes, additions etc. The results will be submitted to major dementia conference(s) for presentation, and submitted for publication in major quality peer-reviewed journal(s). Data will not be used for any purpose other than to do with OA-COG.

Bibliography:

[1] Prince, M. et al., Dementia UK: – overview. 2014.
[2] Tzourio, C., et al., Effects of blood pressure lowering with perindopril and indapamide therapy on dementia and cognitive decline in patients with cerebrovascular disease. Arch Intern Med, 2003. 163(9): p. 1069-75.
[3] Heart Protection Study Collaborative Group, MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20536 high-risk individuals: a randomised placebo-controlled trial. Lancet, 2002. 360: p. 7-22.
[4] Prince, M.J., et al., Is the cognitive function of older patients affected by antihypertensive treatment? Reuslts from 54 months of the Medical Research Council’s treatment trial of hypertension in older adults. British Medical Journal, 1996. 312: p. 801-5.
[5] Simons, M., et al., Treatment with simvastatin in normocholesterolemic patients with Alzheimer’s disease: A 26-week randomized, placebo-controlled, double-blind trial. Ann Neurol, 2002. 52: p. 346-350.
[6] Sparks, D.L., et al., Atorvastatin for the treatment of mild to moderate Alzheimer disease. Arch Neurol, 2005. 62: p. 753-757.
[7] Applegate, W.B., et al., Impact of the treatment of isolated systolic hypertension on behavioral variables. Arch Intern Med, 1994. 154.
[8] Skoog, I., et al., Effect of baseline cognitive function and antihypertensive treatment on cognitive and cardiovascular outcomes: study on COgnition and Prognosis in the Elderly (SCOPE). American Journal of Hypertension, 2005. 18: p. 1052-59.
[9] Shepherd, J., et al., Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet, 2002. 360: p. 1623-1630.
[10] Muldoon, M.F., et al., Randomized trial of the effects of simvastatin on cognitive functioning in hypercholesterolemic adults. The American Journal of Medicine, 2004. 117(11): p. 823-9.
[11] Wardlaw, J.M., et al., Thrombolysis for acute ischaemic stroke. Cochrane Database Systematic Review, 2003(3).
[12] Di Bari, M., et al., Dementia and disability outcomes in large hypertension trials: lessons learned from the systolic hypertension in the elderly program (SHEP) trial. American Journal of Epidemiology, 2001. 153(1): p. 72-78.