ID

30825

Beskrivning

Donepezil and Memantine in Moderate to Severe Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00866060

Länk

https://clinicaltrials.gov/show/NCT00866060

Nyckelord

Versioner (1)
  1. 2018-06-24 2018-06-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Moderate to Severe Alzheimer's Disease NCT00866060

Engelsk

Eligibility Moderate to Severe Alzheimer's Disease NCT00866060

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants will be patients who meet nincds-adrda criteria for probable or possible alzheimer's disease (mckhann et al, 1984). in addition they will meet all of the following criteria:
Beskrivning

Alzheimer's Disease Probable | Alzheimer's Disease Possible

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002395
UMLS CUI [1,2]
C0332148
UMLS CUI [2,1]
C0002395
UMLS CUI [2,2]
C0332149
1. smmse = 5 to 13 (13 chosen as nice threshold of 10 plus 1 sd on smmse score)
Beskrivning

Mini-mental state examination standardized

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0451306
UMLS CUI [1,2]
C0237892
2. continuously prescribed donepezil for at least 3 months
Beskrivning

Donepezil

Datatyp

boolean

Alias
UMLS CUI [1]
C0527316
3. maintained on 10mg donepezil in previous 6 weeks.
Beskrivning

Donepezil Dosage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0527316
UMLS CUI [1,2]
C0178602
4. no changes in prescription of any psychotropic (antipsychotic, antidepressant, benzodiazepine) medication in previous 6 weeks.
Beskrivning

Psychotropic Drugs unchanged | Antipsychotic Agents | Antidepressive Agents | Benzodiazepines

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0442739
UMLS CUI [2]
C0040615
UMLS CUI [3]
C0003289
UMLS CUI [4]
C0005064
5. prescribing clinician considers (based on nice guidance, discussions with patient and carer and clinical judgement) that change of drug treatment (i.e. stop donepezil or introduce memantine) may be appropriate.
Beskrivning

Pharmacotherapy Change considered | Donepezil To be stopped | Memantine Introduce

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0750591
UMLS CUI [2,1]
C0527316
UMLS CUI [2,2]
C1272691
UMLS CUI [3,1]
C0025242
UMLS CUI [3,2]
C1292748
6. patient is community resident and has family or professional carer or is visited on at least a daily basis by carer.
Beskrivning

Lives in a community | Availability of Caregiver

Datatyp

boolean

Alias
UMLS CUI [1]
C0557143
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0085537
7. patient agrees to participate if considered capable (see section 7.5)
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
8. main carer (informal or professional) consents to their own involvement and the patient's involvement -
Beskrivning

Informed Consent Caregiver

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0085537
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
to maximise the generalisability of the study data, exclusions will be kept to a minimum. these will include:
Beskrivning

Exclusion Criteria Minimum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524031
1. patient has severe, unstable or poorly controlled medical conditions apparent from physical examination or clinical history.
Beskrivning

Medical condition Severe Physical Examination | Medical condition Unstable Physical Examination | Medical condition Poorly controlled Physical Examination | Medical condition Severe Medical History | Medical condition Unstable Medical History | Medical condition Poorly controlled Medical History

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0031809
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C3853134
UMLS CUI [3,3]
C0031809
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0262926
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0443343
UMLS CUI [5,3]
C0262926
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C3853134
UMLS CUI [6,3]
C0262926
2. patient is already prescribed memantine.
Beskrivning

Memantine prescribed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025242
UMLS CUI [1,2]
C0278329
3. patient is unable to take trial medications because of contra-indications or previous adverse or allergic reactions.
Beskrivning

Medical contraindication Investigational New Drugs | Adverse reactions Investigational New Drugs | Allergic Reaction Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0013230
4. patient is involved in another clinical trial.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
5. clinician considers patient would not be compliant with trial medication. -
Beskrivning

Compliance behavior Absent Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0013230
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Similar models

Eligibility Moderate to Severe Alzheimer's Disease NCT00866060

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Alzheimer's Disease Probable | Alzheimer's Disease Possible
Item
participants will be patients who meet nincds-adrda criteria for probable or possible alzheimer's disease (mckhann et al, 1984). in addition they will meet all of the following criteria:
boolean
C0002395 (UMLS CUI [1,1])
C0332148 (UMLS CUI [1,2])
C0002395 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
Mini-mental state examination standardized
Item
1. smmse = 5 to 13 (13 chosen as nice threshold of 10 plus 1 sd on smmse score)
boolean
C0451306 (UMLS CUI [1,1])
C0237892 (UMLS CUI [1,2])
Donepezil
Item
2. continuously prescribed donepezil for at least 3 months
boolean
C0527316 (UMLS CUI [1])
Donepezil Dosage
Item
3. maintained on 10mg donepezil in previous 6 weeks.
boolean
C0527316 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Psychotropic Drugs unchanged | Antipsychotic Agents | Antidepressive Agents | Benzodiazepines
Item
4. no changes in prescription of any psychotropic (antipsychotic, antidepressant, benzodiazepine) medication in previous 6 weeks.
boolean
C0033978 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2])
C0003289 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
Pharmacotherapy Change considered | Donepezil To be stopped | Memantine Introduce
Item
5. prescribing clinician considers (based on nice guidance, discussions with patient and carer and clinical judgement) that change of drug treatment (i.e. stop donepezil or introduce memantine) may be appropriate.
boolean
C0013216 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0750591 (UMLS CUI [1,3])
C0527316 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0025242 (UMLS CUI [3,1])
C1292748 (UMLS CUI [3,2])
Lives in a community | Availability of Caregiver
Item
6. patient is community resident and has family or professional carer or is visited on at least a daily basis by carer.
boolean
C0557143 (UMLS CUI [1])
C0470187 (UMLS CUI [2,1])
C0085537 (UMLS CUI [2,2])
Informed Consent
Item
7. patient agrees to participate if considered capable (see section 7.5)
boolean
C0021430 (UMLS CUI [1])
Informed Consent Caregiver
Item
8. main carer (informal or professional) consents to their own involvement and the patient's involvement -
boolean
C0021430 (UMLS CUI [1,1])
C0085537 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Minimum
Item
to maximise the generalisability of the study data, exclusions will be kept to a minimum. these will include:
boolean
C0680251 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Medical condition Severe Physical Examination | Medical condition Unstable Physical Examination | Medical condition Poorly controlled Physical Examination | Medical condition Severe Medical History | Medical condition Unstable Medical History | Medical condition Poorly controlled Medical History
Item
1. patient has severe, unstable or poorly controlled medical conditions apparent from physical examination or clinical history.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0031809 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0262926 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0262926 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C3853134 (UMLS CUI [6,2])
C0262926 (UMLS CUI [6,3])
Memantine prescribed
Item
2. patient is already prescribed memantine.
boolean
C0025242 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
Medical contraindication Investigational New Drugs | Adverse reactions Investigational New Drugs | Allergic Reaction Investigational New Drugs
Item
3. patient is unable to take trial medications because of contra-indications or previous adverse or allergic reactions.
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
Study Subject Participation Status
Item
4. patient is involved in another clinical trial.
boolean
C2348568 (UMLS CUI [1])
Compliance behavior Absent Investigational New Drugs
Item
5. clinician considers patient would not be compliant with trial medication. -
boolean
C1321605 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
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