ID

14227

Beschreibung

The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00255086

Link

https://clinicaltrials.gov/show/NCT00255086

Stichworte

Versionen (1)
  1. 05.04.16 05.04.16 -
Hochgeladen am

5. April 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Alzheimer Disease NCT00255086

Englisch

Eligibility Alzheimer Disease NCT00255086

1 Formulare  
Criteria
Beschreibung

Criteria

2. 50-95 years of age inclusive.
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. mmse at screen and baseline 7-28 inclusive.
Beschreibung

Mini-mental state examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0451306
4. conversant in english.
Beschreibung

english speaking

Datentyp

boolean

Alias
UMLS CUI [1]
C0376245
5. caregiver/study partner willing to participate, supervise the patient and be available for administration of study medication.
Beschreibung

compliance behaviour caregiver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0085537
6. able to ingest oral medication.
Beschreibung

oral medication intake

Datentyp

boolean

Alias
UMLS CUI [1]
C2222393
exclusion criteria:1. history of clinically significant stroke without substantial recovery.
Beschreibung

exclusion criteria; stroke

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0038454
2. neurological or medical conditions causing significant disability independent of dementia.
Beschreibung

neurological conditions; dementia

Datentyp

boolean

Alias
UMLS CUI [1]
C2359473
UMLS CUI [2]
C0497327
3. parkinson's disease.
Beschreibung

parkinsons disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0030567
4. history in past two years of focal brain lesion, head injury with loss of consciousness or dsm-iv criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
Beschreibung

brain lesion; head injury; dsm-iv classification; Unconscious State; psychiatric disorder; psychosis; bipolar disorder; substance abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0221505
UMLS CUI [2]
C0455587
UMLS CUI [3]
C0236962
UMLS CUI [4]
C0041657
UMLS CUI [5]
C0004936
UMLS CUI [6]
C0033975
UMLS CUI [7]
C0005586
UMLS CUI [8]
C0687130
5. dementia due to korsakoff's syndrome or infectious diseases such as creutzfeldt-jakob disease, herpes, encephalitis, or human immunodeficiency virus.
Beschreibung

dementia; Wernicke-Korsakoff Syndrome; creutzfeldt-jakob disease; encephalitis; human immunodeficiency virus

Datentyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0349464
UMLS CUI [3]
C0022336
UMLS CUI [4]
C0014038
UMLS CUI [5]
C0019682
6. sensory impairment that would prevent subject from participating in or cooperating with the protocol.
Beschreibung

Compliance behavior Limited sensory impairment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0020580
7. significant clinical disorder or laboratory finding that renders the subject unsuitable for receiving an investigational drug including: clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality.
Beschreibung

Compliance behavior Limited Comorbidity; systemic disease; laboratory abnormality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C0442893
UMLS CUI [3]
C0438215
8. clinical contraindication to the use of memantine (e.g., hypersensitivity).
Beschreibung

medical contraindication memantine; hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025242
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0025242
9. history of seizure within past 5 years prior to screening.
Beschreibung

medical history seizure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0036572
10. platelet count < 100,000/mm3.
Beschreibung

platelet count

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
11. history of claustrophobia
Beschreibung

medical history claustrophobia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0008909
12. presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body
Beschreibung

implants metallic pacemakers aneurysm clips

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C2986473
UMLS CUI [1,3]
C0810633
UMLS CUI [1,4]
C0179977
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Ähnliche Modelle

Eligibility Alzheimer Disease NCT00255086

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
age
Item
2. 50-95 years of age inclusive.
boolean
C0001779 (UMLS CUI [1])
Mini-mental state examination
Item
3. mmse at screen and baseline 7-28 inclusive.
boolean
C0451306 (UMLS CUI [1])
english speaking
Item
4. conversant in english.
boolean
C0376245 (UMLS CUI [1])
compliance behaviour caregiver
Item
5. caregiver/study partner willing to participate, supervise the patient and be available for administration of study medication.
boolean
C1321605 (UMLS CUI [1,1])
C0085537 (UMLS CUI [1,2])
oral medication intake
Item
6. able to ingest oral medication.
boolean
C2222393 (UMLS CUI [1])
exclusion criteria; stroke
Item
exclusion criteria:1. history of clinically significant stroke without substantial recovery.
boolean
C0680251 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
neurological conditions; dementia
Item
2. neurological or medical conditions causing significant disability independent of dementia.
boolean
C2359473 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
parkinsons disease
Item
3. parkinson's disease.
boolean
C0030567 (UMLS CUI [1])
brain lesion; head injury; dsm-iv classification; Unconscious State; psychiatric disorder; psychosis; bipolar disorder; substance abuse
Item
4. history in past two years of focal brain lesion, head injury with loss of consciousness or dsm-iv criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
boolean
C0221505 (UMLS CUI [1])
C0455587 (UMLS CUI [2])
C0236962 (UMLS CUI [3])
C0041657 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
C0033975 (UMLS CUI [6])
C0005586 (UMLS CUI [7])
C0687130 (UMLS CUI [8])
dementia; Wernicke-Korsakoff Syndrome; creutzfeldt-jakob disease; encephalitis; human immunodeficiency virus
Item
5. dementia due to korsakoff's syndrome or infectious diseases such as creutzfeldt-jakob disease, herpes, encephalitis, or human immunodeficiency virus.
boolean
C0497327 (UMLS CUI [1])
C0349464 (UMLS CUI [2])
C0022336 (UMLS CUI [3])
C0014038 (UMLS CUI [4])
C0019682 (UMLS CUI [5])
Compliance behavior Limited sensory impairment
Item
6. sensory impairment that would prevent subject from participating in or cooperating with the protocol.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0020580 (UMLS CUI [1,3])
Compliance behavior Limited Comorbidity; systemic disease; laboratory abnormality
Item
7. significant clinical disorder or laboratory finding that renders the subject unsuitable for receiving an investigational drug including: clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2])
C0438215 (UMLS CUI [3])
medical contraindication memantine; hypersensitivity
Item
8. clinical contraindication to the use of memantine (e.g., hypersensitivity).
boolean
C1301624 (UMLS CUI [1,1])
C0025242 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0025242 (UMLS CUI [2,2])
medical history seizure
Item
9. history of seizure within past 5 years prior to screening.
boolean
C0262926 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
platelet count
Item
10. platelet count < 100,000/mm3.
boolean
C0032181 (UMLS CUI [1])
medical history claustrophobia
Item
11. history of claustrophobia
boolean
C0262926 (UMLS CUI [1,1])
C0008909 (UMLS CUI [1,2])
implants metallic pacemakers aneurysm clips
Item
12. presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body
boolean
C0021102 (UMLS CUI [1,1])
C2986473 (UMLS CUI [1,2])
C0810633 (UMLS CUI [1,3])
C0179977 (UMLS CUI [1,4])
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