ID

30814

Descrição

An Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNK 754 in Elderly Volunteers and in Subjects With Mild Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01013610

Link

https://clinicaltrials.gov/show/NCT01013610

Palavras-chave

Versões (2)
  1. 21/06/2018 21/06/2018 -
  2. 22/06/2018 22/06/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

22 de junho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Mild Alzheimer's Disease NCT01013610

Inglês

Eligibility Mild Alzheimer's Disease NCT01013610

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
part a and part b:
Descrição

Clinical Trial Part Roman letter Roman letter

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0439102
UMLS CUI [1,4]
C0439102
1. males or females aged 60 years or older. females must be surgically sterilized or postmenopausal for at least two years. males must be actively practicing double-barrier contraception (condom plus spermicide), unless they have had a vasectomy, or their partner(s) meet the above criteria for females.
Descrição

Age | Female Sterilization | Postmenopausal state | Gender Barrier Contraception Double | Condoms, Male | Spermatocidal Agents | Exception Vasectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0004764
UMLS CUI [4,3]
C0205173
UMLS CUI [5]
C0009653
UMLS CUI [6]
C0037862
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0042387
2. voluntarily consent to participate in this study and provide written informed consent prior to start of any study-specific procedures.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
3. be prepared to adhere to the protocol requirements and be willing and able to remain in the study unit for the entire duration of the confinement period. they must also be willing to return for the end-of-study visit one week after the last dosing.
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
part a only:
Descrição

Clinical Trial Part Roman letter

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0439102
4. subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. subjects may be included with clinical deviations from normal limits in medical history, physical examination, vital sign measurements, ecg, or laboratory test results that are associated with stable, well controlled chronic illness. subjects with concomitant diseases or using concomitant medication will be allowed to participate provided a stable condition and stable treatment for 1 month (30 days) prior to administration of the first dose of study medication. inclusion of each subject will be reviewed with the link medical monitor prior to enrollment in the trial.
Descrição

Good Health General | Chronic disease Stable Well controlled | Interference Study Objective Absent | Normal limits Deviation Medical History | Normal limits Deviation Physical Examination | Normal limits Deviation Vital signs | Normal limits Deviation Electrocardiography | Normal limits Deviation Laboratory Results | Comorbidity Stable | Concomitant Agent allowed | Therapeutic procedure Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3813622
UMLS CUI [1,2]
C0205246
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C3853142
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C2985627
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0442816
UMLS CUI [4,2]
C0205419
UMLS CUI [4,3]
C0262926
UMLS CUI [5,1]
C0442816
UMLS CUI [5,2]
C0205419
UMLS CUI [5,3]
C0031809
UMLS CUI [6,1]
C0442816
UMLS CUI [6,2]
C0205419
UMLS CUI [6,3]
C0518766
UMLS CUI [7,1]
C0442816
UMLS CUI [7,2]
C0205419
UMLS CUI [7,3]
C1623258
UMLS CUI [8,1]
C0442816
UMLS CUI [8,2]
C0205419
UMLS CUI [8,3]
C1254595
UMLS CUI [9,1]
C0009488
UMLS CUI [9,2]
C0205360
UMLS CUI [10,1]
C2347852
UMLS CUI [10,2]
C0683607
UMLS CUI [11,1]
C0087111
UMLS CUI [11,2]
C0205360
part b only:
Descrição

Clinical Trial Part Roman letter

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0439102
5. subjects with mild alzheimer's disease, as defined by dsm-iv.
Descrição

Alzheimer's Disease Mild

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0002395
UMLS CUI [1,2]
C2945599
6. subjects with a score of ≥ 18-26 on the mini-mental state examination (mmse).
Descrição

Mini-mental state examination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451306
7. subjects with a clinical dementia rating (cdr) total score of 0.5 or 1.0 (possible or mild dementia).
Descrição

CDR (Clinical Dementia Rating) score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4304227
8. subjects with a rosen-modified hachinski ischemic score of ≤ 4.
Descrição

Hachinski ischemia score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0475492
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
part a and part b:
Descrição

Clinical Trial Part Roman letter Roman letter

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0439102
UMLS CUI [1,4]
C0439102
1. any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease, as determined by medical history, physical examination or laboratory tests.
Descrição

Cardiovascular Diseases Unstable | Liver diseases Unstable | Kidney Diseases Unstable | Respiration Disorders Unstable | Gastrointestinal Diseases Unstable | Endocrine System Diseases Unstable | Immune System Diseases Unstable | Dermatologic disorders Unstable | Hematological Disease Unstable | Nervous system disorder Unstable | Mental disorders Unstable | Cardiovascular Diseases Uncontrolled | Liver diseases Uncontrolled | Kidney Diseases Uncontrolled | Respiration Disorders Uncontrolled | Gastrointestinal Diseases Uncontrolled | Endocrine System Diseases Uncontrolled | Immune System Diseases Uncontrolled | Dermatologic disorders Uncontrolled | Hematological Disease Uncontrolled | Nervous system disorder Uncontrolled | Mental disorders Uncontrolled | Medical History | Physical Examination | Laboratory Procedures

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0035204
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0017178
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0014130
UMLS CUI [6,2]
C0443343
UMLS CUI [7,1]
C0021053
UMLS CUI [7,2]
C0443343
UMLS CUI [8,1]
C0037274
UMLS CUI [8,2]
C0443343
UMLS CUI [9,1]
C0018939
UMLS CUI [9,2]
C0443343
UMLS CUI [10,1]
C0027765
UMLS CUI [10,2]
C0443343
UMLS CUI [11,1]
C0004936
UMLS CUI [11,2]
C0443343
UMLS CUI [12,1]
C0007222
UMLS CUI [12,2]
C0205318
UMLS CUI [13,1]
C0023895
UMLS CUI [13,2]
C0205318
UMLS CUI [14,1]
C0022658
UMLS CUI [14,2]
C0205318
UMLS CUI [15,1]
C0035204
UMLS CUI [15,2]
C0205318
UMLS CUI [16,1]
C0017178
UMLS CUI [16,2]
C0205318
UMLS CUI [17,1]
C0014130
UMLS CUI [17,2]
C0205318
UMLS CUI [18,1]
C0021053
UMLS CUI [18,2]
C0205318
UMLS CUI [19,1]
C0037274
UMLS CUI [19,2]
C0205318
UMLS CUI [20,1]
C0018939
UMLS CUI [20,2]
C0205318
UMLS CUI [21,1]
C0027765
UMLS CUI [21,2]
C0205318
UMLS CUI [22,1]
C0004936
UMLS CUI [22,2]
C0205318
UMLS CUI [23]
C0262926
UMLS CUI [24]
C0031809
UMLS CUI [25]
C0022885
2. subjects who have positive serologic findings for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), and/or hepatitis c virus (hcv) antibodies.
Descrição

HIV Seropositivity | Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis C Antibodies

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019168
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0166049
3. subjects who have received any experimental drugs or devices within 30 days prior to dosing or who wish to receive any experimental drug within 30 days after completing the study.
Descrição

Investigational New Drugs | Investigational Medical Device | Desire Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
UMLS CUI [3,1]
C0871633
UMLS CUI [3,2]
C0013230
4. subjects unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
Descrição

Study Protocol Comprehension Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Mild Alzheimer's Disease NCT01013610

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Part Roman letter Roman letter
Item
part a and part b:
boolean
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0439102 (UMLS CUI [1,3])
C0439102 (UMLS CUI [1,4])
Age | Female Sterilization | Postmenopausal state | Gender Barrier Contraception Double | Condoms, Male | Spermatocidal Agents | Exception Vasectomy
Item
1. males or females aged 60 years or older. females must be surgically sterilized or postmenopausal for at least two years. males must be actively practicing double-barrier contraception (condom plus spermicide), unless they have had a vasectomy, or their partner(s) meet the above criteria for females.
boolean
C0001779 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0004764 (UMLS CUI [4,2])
C0205173 (UMLS CUI [4,3])
C0009653 (UMLS CUI [5])
C0037862 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0042387 (UMLS CUI [7,2])
Informed Consent
Item
2. voluntarily consent to participate in this study and provide written informed consent prior to start of any study-specific procedures.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
3. be prepared to adhere to the protocol requirements and be willing and able to remain in the study unit for the entire duration of the confinement period. they must also be willing to return for the end-of-study visit one week after the last dosing.
boolean
C0525058 (UMLS CUI [1])
Clinical Trial Part Roman letter
Item
part a only:
boolean
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0439102 (UMLS CUI [1,3])
Good Health General | Chronic disease Stable Well controlled | Interference Study Objective Absent | Normal limits Deviation Medical History | Normal limits Deviation Physical Examination | Normal limits Deviation Vital signs | Normal limits Deviation Electrocardiography | Normal limits Deviation Laboratory Results | Comorbidity Stable | Concomitant Agent allowed | Therapeutic procedure Stable
Item
4. subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. subjects may be included with clinical deviations from normal limits in medical history, physical examination, vital sign measurements, ecg, or laboratory test results that are associated with stable, well controlled chronic illness. subjects with concomitant diseases or using concomitant medication will be allowed to participate provided a stable condition and stable treatment for 1 month (30 days) prior to administration of the first dose of study medication. inclusion of each subject will be reviewed with the link medical monitor prior to enrollment in the trial.
boolean
C3813622 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C3853142 (UMLS CUI [2,3])
C0521102 (UMLS CUI [3,1])
C2985627 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0442816 (UMLS CUI [4,1])
C0205419 (UMLS CUI [4,2])
C0262926 (UMLS CUI [4,3])
C0442816 (UMLS CUI [5,1])
C0205419 (UMLS CUI [5,2])
C0031809 (UMLS CUI [5,3])
C0442816 (UMLS CUI [6,1])
C0205419 (UMLS CUI [6,2])
C0518766 (UMLS CUI [6,3])
C0442816 (UMLS CUI [7,1])
C0205419 (UMLS CUI [7,2])
C1623258 (UMLS CUI [7,3])
C0442816 (UMLS CUI [8,1])
C0205419 (UMLS CUI [8,2])
C1254595 (UMLS CUI [8,3])
C0009488 (UMLS CUI [9,1])
C0205360 (UMLS CUI [9,2])
C2347852 (UMLS CUI [10,1])
C0683607 (UMLS CUI [10,2])
C0087111 (UMLS CUI [11,1])
C0205360 (UMLS CUI [11,2])
Clinical Trial Part Roman letter
Item
part b only:
boolean
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0439102 (UMLS CUI [1,3])
Alzheimer's Disease Mild
Item
5. subjects with mild alzheimer's disease, as defined by dsm-iv.
boolean
C0002395 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
Mini-mental state examination
Item
6. subjects with a score of ≥ 18-26 on the mini-mental state examination (mmse).
boolean
C0451306 (UMLS CUI [1])
CDR (Clinical Dementia Rating) score
Item
7. subjects with a clinical dementia rating (cdr) total score of 0.5 or 1.0 (possible or mild dementia).
boolean
C4304227 (UMLS CUI [1])
Hachinski ischemia score
Item
8. subjects with a rosen-modified hachinski ischemic score of ≤ 4.
boolean
C0475492 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Clinical Trial Part Roman letter Roman letter
Item
part a and part b:
boolean
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0439102 (UMLS CUI [1,3])
C0439102 (UMLS CUI [1,4])
Cardiovascular Diseases Unstable | Liver diseases Unstable | Kidney Diseases Unstable | Respiration Disorders Unstable | Gastrointestinal Diseases Unstable | Endocrine System Diseases Unstable | Immune System Diseases Unstable | Dermatologic disorders Unstable | Hematological Disease Unstable | Nervous system disorder Unstable | Mental disorders Unstable | Cardiovascular Diseases Uncontrolled | Liver diseases Uncontrolled | Kidney Diseases Uncontrolled | Respiration Disorders Uncontrolled | Gastrointestinal Diseases Uncontrolled | Endocrine System Diseases Uncontrolled | Immune System Diseases Uncontrolled | Dermatologic disorders Uncontrolled | Hematological Disease Uncontrolled | Nervous system disorder Uncontrolled | Mental disorders Uncontrolled | Medical History | Physical Examination | Laboratory Procedures
Item
1. any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease, as determined by medical history, physical examination or laboratory tests.
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0035204 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0017178 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0014130 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0021053 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0037274 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0018939 (UMLS CUI [9,1])
C0443343 (UMLS CUI [9,2])
C0027765 (UMLS CUI [10,1])
C0443343 (UMLS CUI [10,2])
C0004936 (UMLS CUI [11,1])
C0443343 (UMLS CUI [11,2])
C0007222 (UMLS CUI [12,1])
C0205318 (UMLS CUI [12,2])
C0023895 (UMLS CUI [13,1])
C0205318 (UMLS CUI [13,2])
C0022658 (UMLS CUI [14,1])
C0205318 (UMLS CUI [14,2])
C0035204 (UMLS CUI [15,1])
C0205318 (UMLS CUI [15,2])
C0017178 (UMLS CUI [16,1])
C0205318 (UMLS CUI [16,2])
C0014130 (UMLS CUI [17,1])
C0205318 (UMLS CUI [17,2])
C0021053 (UMLS CUI [18,1])
C0205318 (UMLS CUI [18,2])
C0037274 (UMLS CUI [19,1])
C0205318 (UMLS CUI [19,2])
C0018939 (UMLS CUI [20,1])
C0205318 (UMLS CUI [20,2])
C0027765 (UMLS CUI [21,1])
C0205318 (UMLS CUI [21,2])
C0004936 (UMLS CUI [22,1])
C0205318 (UMLS CUI [22,2])
C0262926 (UMLS CUI [23])
C0031809 (UMLS CUI [24])
C0022885 (UMLS CUI [25])
HIV Seropositivity | Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis C Antibodies
Item
2. subjects who have positive serologic findings for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), and/or hepatitis c virus (hcv) antibodies.
boolean
C0019699 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0019168 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0166049 (UMLS CUI [3,2])
Investigational New Drugs | Investigational Medical Device | Desire Investigational New Drugs
Item
3. subjects who have received any experimental drugs or devices within 30 days prior to dosing or who wish to receive any experimental drug within 30 days after completing the study.
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0871633 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
Study Protocol Comprehension Unable
Item
4. subjects unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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