ID

14237

Beschreibung

Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00481520

Link

https://clinicaltrials.gov/show/NCT00481520

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 NCT00481520

Englisch

Eligibility Alzheimer Disease NCT00481520

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed and dated written informed consent obtained from the subject or the subject`s legally authorized representative (lar) or next of kin (if applicable), in accordance with the local regulations. the subject`s caregiver must also consent to participate in the study.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. diagnosis of probable alzheimer's disease according to national institute of neurological and communicative disorders and stroke-alzheimer's disease and related disorders association (nincds-adrda) criteria.
Beschreibung

alzheimers disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0002395
3. men and postmenopausal or surgically sterile women aged from 50 to 90 inclusive. postmenopausal women must have had 12 months of spontaneous amenorrhea. surgically sterile women are defined as having a hysterectomy, bilateral ovariectomy [oophorectomy], or bilateral tubal ligation. men who are sexually active will need to agree to use a form of contraception that is satisfactory as per the investigator.
Beschreibung

gender; age; postmenopausal; amenorrhea; hysterectomy; bilateral ovariectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0002453
UMLS CUI [5]
C0020699
UMLS CUI [6]
C0278321
4. able to participate in all scheduled evaluations with a high probability of completing all required procedures and neuropsychological tests.
Beschreibung

compliance behaviour

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. significant neurological disease other than alzheimer's disease, which may affect cognition (eg, epilepsy, parkinson disease).
Beschreibung

neurological disease; epilepsy; parkinson disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0030567
2. current diagnosis of a major depressive disorder or other major psychiatric symptom according to the criteria of diagnostic and statistical manual of mental disorders, fourth edition text version (dsm-iv-tr).
Beschreibung

depressive disorder; psychiatric symptom; dsm-iv-tr

Datentyp

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0233401
UMLS CUI [3]
C3710317
3. current clinically significant systemic illness, which is likely to deteriorate or affect the subject's safety, influence cognitive assessment or ability to complete the study.
Beschreibung

Compliance behavior Limited Comorbidity Systemic disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [1,4]
C0442893
4. any clinically important deviation from normal limits in physical and neurological examination, vital signs, on electrocardiogram (ecg) or clinical laboratory test results that could compromise the study or be detrimental to the subject.
Beschreibung

physical examination; vital signs; electrocardiogram

Datentyp

boolean

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0518766
UMLS CUI [3]
C0013798
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Ähnliche Modelle

Eligibility Alzheimer Disease NCT00481520

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
1. signed and dated written informed consent obtained from the subject or the subject`s legally authorized representative (lar) or next of kin (if applicable), in accordance with the local regulations. the subject`s caregiver must also consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
alzheimers disease
Item
2. diagnosis of probable alzheimer's disease according to national institute of neurological and communicative disorders and stroke-alzheimer's disease and related disorders association (nincds-adrda) criteria.
boolean
C0002395 (UMLS CUI [1])
gender; age; postmenopausal; amenorrhea; hysterectomy; bilateral ovariectomy
Item
3. men and postmenopausal or surgically sterile women aged from 50 to 90 inclusive. postmenopausal women must have had 12 months of spontaneous amenorrhea. surgically sterile women are defined as having a hysterectomy, bilateral ovariectomy [oophorectomy], or bilateral tubal ligation. men who are sexually active will need to agree to use a form of contraception that is satisfactory as per the investigator.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0002453 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0278321 (UMLS CUI [6])
compliance behaviour
Item
4. able to participate in all scheduled evaluations with a high probability of completing all required procedures and neuropsychological tests.
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
neurological disease; epilepsy; parkinson disease
Item
1. significant neurological disease other than alzheimer's disease, which may affect cognition (eg, epilepsy, parkinson disease).
boolean
C0027765 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0030567 (UMLS CUI [3])
depressive disorder; psychiatric symptom; dsm-iv-tr
Item
2. current diagnosis of a major depressive disorder or other major psychiatric symptom according to the criteria of diagnostic and statistical manual of mental disorders, fourth edition text version (dsm-iv-tr).
boolean
C0011581 (UMLS CUI [1])
C0233401 (UMLS CUI [2])
C3710317 (UMLS CUI [3])
Compliance behavior Limited Comorbidity Systemic disease
Item
3. current clinically significant systemic illness, which is likely to deteriorate or affect the subject's safety, influence cognitive assessment or ability to complete the study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0442893 (UMLS CUI [1,4])
physical examination; vital signs; electrocardiogram
Item
4. any clinically important deviation from normal limits in physical and neurological examination, vital signs, on electrocardiogram (ecg) or clinical laboratory test results that could compromise the study or be detrimental to the subject.
boolean
C0031809 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
C0013798 (UMLS CUI [3])
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