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])
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])