ID

21540

Description

Namenda (Memantine) for Non-Motor Symptoms in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00646204

Lien

https://clinicaltrials.gov/show/NCT00646204

Mots-clés

Versions (1)
  1. 26/04/2017 26/04/2017 -
Téléchargé le

26 avril 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00646204

Anglais

Eligibility Parkinson's Disease NCT00646204

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects must be between the ages of 18 and 80 inclusive.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. each subject must meet standard criteria for pd.
Description

Standard criteria for parkinson's disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0030567
3. all patients on dopaminergic therapy must report benefit. -no other abnormal neurological signs. -no direct or indirect trauma to the nervous system within 3 months preceding the onset of pd. -no convincing evidence of sudden onset or evidence of stepwise deterioration.
Description

Benefit from dopaminergic therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013036
UMLS CUI [1,2]
C0814225
4. subjects must be in generally good health as evidenced by previous medical history and clinical examination.
Description

Health Status

Type de données

boolean

Alias
UMLS CUI [1]
C0018759
5. subjects will be allowed to take any pd medication with the exception of amantadine. they will also be allowed to take medications approved for the use of alzheimer's disease.
Description

Pharmacotherapy for Parkinson except amantadine; pharmacotherapy for alzheimer's disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0030567
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C0002403
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0002395
6. subjects will be required to be on a stable dose of all medications for at least two weeks prior to entry into the study and may not alter these medications throughout the study.
Description

Stable dosage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0178602
7. if subjects are on an anti-depressant medications, a stable dose of these will be required for at least six weeks prior to entry into the study.
Description

Antidepressant medication

Type de données

boolean

Alias
UMLS CUI [1]
C0003289
8. subjects must be accessible by telephone.
Description

Telephone

Type de données

boolean

Alias
UMLS CUI [1]
C1515258
9. if the subject is a female of childbearing age, she must have had: a hysterectomy, or tubal ligation, or otherwise be incapable or pregnancy, or have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility.
Description

Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1]
C0700589
10. female of childbearing age must have had a negative urine pregnancy test within one week of study entry. 11. prior to participation in this study, each subject must sign an informed consent.
Description

Pregnancy and Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects who do not meet inclusion criteria.
Description

Inclusion Criteria

Type de données

boolean

Alias
UMLS CUI [1]
C1512693
2. subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation.
Description

Substance Use Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
3. subjects who can not maintain an identical dose of any medicine that may affect pd symptoms or signs during their entire study involvement.
Description

Pharmacotherapy affecting Parkinson's disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0030567
4. subjects who have exhibited meaningful psychiatric disease not thought to be related to pd. (depression and psychosis typical for pd will not be excluded). 5. subjects who have previously taken memantine.
Description

Mental disorder and Memantine

Type de données

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0025242
6. subjects currently taking amantadine. 7. subjects with greater than moderate dementia (mmse<24). 8. subjects with co-morbid disease that in the investigators decision could interfere with treatment with memantine.
Description

Amantadine, MMSE, Comorbidity

Type de données

boolean

Alias
UMLS CUI [1]
C0002403
UMLS CUI [2]
C0451306
UMLS CUI [3]
C0009488
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Similar models

Eligibility Parkinson's Disease NCT00646204

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subjects must be between the ages of 18 and 80 inclusive.
boolean
C0001779 (UMLS CUI [1])
Standard criteria for parkinson's disease
Item
2. each subject must meet standard criteria for pd.
boolean
C0243161 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Benefit from dopaminergic therapy
Item
3. all patients on dopaminergic therapy must report benefit. -no other abnormal neurological signs. -no direct or indirect trauma to the nervous system within 3 months preceding the onset of pd. -no convincing evidence of sudden onset or evidence of stepwise deterioration.
boolean
C0013036 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
Health Status
Item
4. subjects must be in generally good health as evidenced by previous medical history and clinical examination.
boolean
C0018759 (UMLS CUI [1])
Pharmacotherapy for Parkinson except amantadine; pharmacotherapy for alzheimer's disease
Item
5. subjects will be allowed to take any pd medication with the exception of amantadine. they will also be allowed to take medications approved for the use of alzheimer's disease.
boolean
C0013216 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0002403 (UMLS CUI [1,4])
C0013216 (UMLS CUI [2,1])
C0002395 (UMLS CUI [2,2])
Stable dosage
Item
6. subjects will be required to be on a stable dose of all medications for at least two weeks prior to entry into the study and may not alter these medications throughout the study.
boolean
C0205360 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Antidepressant medication
Item
7. if subjects are on an anti-depressant medications, a stable dose of these will be required for at least six weeks prior to entry into the study.
boolean
C0003289 (UMLS CUI [1])
Telephone
Item
8. subjects must be accessible by telephone.
boolean
C1515258 (UMLS CUI [1])
Contraceptive methods
Item
9. if the subject is a female of childbearing age, she must have had: a hysterectomy, or tubal ligation, or otherwise be incapable or pregnancy, or have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility.
boolean
C0700589 (UMLS CUI [1])
Pregnancy and Informed Consent
Item
10. female of childbearing age must have had a negative urine pregnancy test within one week of study entry. 11. prior to participation in this study, each subject must sign an informed consent.
boolean
C0032961 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Inclusion Criteria
Item
1. subjects who do not meet inclusion criteria.
boolean
C1512693 (UMLS CUI [1])
Substance Use Disorder
Item
2. subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation.
boolean
C0038586 (UMLS CUI [1])
Pharmacotherapy affecting Parkinson's disease
Item
3. subjects who can not maintain an identical dose of any medicine that may affect pd symptoms or signs during their entire study involvement.
boolean
C0013216 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Mental disorder and Memantine
Item
4. subjects who have exhibited meaningful psychiatric disease not thought to be related to pd. (depression and psychosis typical for pd will not be excluded). 5. subjects who have previously taken memantine.
boolean
C0004936 (UMLS CUI [1])
C0025242 (UMLS CUI [2])
Amantadine, MMSE, Comorbidity
Item
6. subjects currently taking amantadine. 7. subjects with greater than moderate dementia (mmse<24). 8. subjects with co-morbid disease that in the investigators decision could interfere with treatment with memantine.
boolean
C0002403 (UMLS CUI [1])
C0451306 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
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