ID

43592

Description

Evaluation of [123I] AV51 and SPECT as a Marker of Beta-Amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00556660

Link

https://clinicaltrials.gov/show/NCT00556660

Keywords

Versions (2)
  1. 4/17/16 4/17/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Alzheimer Disease NCT00556660

English

Eligibility Alzheimer Disease NCT00556660

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy control subject selection. healthy control subjects who have no neurological disease will be recruited for this study. the following criteria will be met for inclusion of healthy control subjects in this study:
Description

healthy; neurological disease

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0027765
the participant is 50 years or older.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent is obtained.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
negative history of neurological or psychiatric illness based on evaluation by a research physician.
Description

neurological disease

Data type

boolean

Alias
UMLS CUI [1]
C0027765
mini-mental status exam score ≥28.
Description

mini mental status examination

Data type

boolean

Alias
UMLS CUI [1]
C0451306
for females, non-child bearing potential or negative urine or blood pregnancy test on day of 123-i av51 injection.
Description

contraception status; pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0420837
UMLS CUI [2]
C0427780
alzheimer's subject selection. subjects who have a clinical diagnosis of mild to moderate alzheimer's disease will be recruited for this study. the following criteria will be met for inclusion of ad subjects in this study:
Description

alzheimers disease

Data type

boolean

Alias
UMLS CUI [1]
C0002395
the participant is 50 years or older.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent is obtained.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
participants have a clinical diagnosis of alzheimer's disease based on national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association (nincds/adrda) criteria.
Description

alzheimers disease; NINCDS-ADRDA Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0002395
UMLS CUI [2]
C2828081
mini-mental status exam score < 25.
Description

mini-mental status exam score

Data type

boolean

Alias
UMLS CUI [1]
C2225229
modified hachinski ischemia scale score of ≤ 4.
Description

hachinski ischemia scale score

Data type

boolean

Alias
UMLS CUI [1]
C0475492
geriatric depression scales (gds) ≤ 10.
Description

depression scales geriatric

Data type

boolean

Alias
UMLS CUI [1,1]
C0679604
UMLS CUI [1,2]
C1704440
for females, non-child bearing potential or negative urine or blood pregnancy test on day of 123-i av51 injection.
Description

contraception status; pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0420837
UMLS CUI [2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
healthy control subjects will be excluded from participation for the following reasons:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
the subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
Description

psychiatric illness

Data type

boolean

Alias
UMLS CUI [1]
C0004936
the subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
Description

Compliance behavior Limited Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
the subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
Description

Compliance behavior Limited Comorbidity gastrointenstinal disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [1,4]
C0017178
pregnancy
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0549206
alzheimer's subjects will be excluded from participation for the following reasons:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
the subject has signs or symptoms of another neurodegenerative disease including parkinson's disease, diffuse lewy body dementia, or history of significant cerebrovascular disease.
Description

neurodegenerative disease; parkinsons disease; dementia; cerebrovascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0524851
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0497327
UMLS CUI [4]
C0007820
the subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
Description

psychiatric illness

Data type

boolean

Alias
UMLS CUI [1]
C0004936
the subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery)
Description

Compliance behavior Limited Comorbidity; gastrointestinal surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C0524722
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Similar models

Eligibility Alzheimer Disease NCT00556660

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
healthy; neurological disease
Item
healthy control subject selection. healthy control subjects who have no neurological disease will be recruited for this study. the following criteria will be met for inclusion of healthy control subjects in this study:
boolean
C1708335 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
age
Item
the participant is 50 years or older.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
written informed consent is obtained.
boolean
C0021430 (UMLS CUI [1])
neurological disease
Item
negative history of neurological or psychiatric illness based on evaluation by a research physician.
boolean
C0027765 (UMLS CUI [1])
mini mental status examination
Item
mini-mental status exam score ≥28.
boolean
C0451306 (UMLS CUI [1])
contraception status; pregnancy test negative
Item
for females, non-child bearing potential or negative urine or blood pregnancy test on day of 123-i av51 injection.
boolean
C0420837 (UMLS CUI [1])
C0427780 (UMLS CUI [2])
alzheimers disease
Item
alzheimer's subject selection. subjects who have a clinical diagnosis of mild to moderate alzheimer's disease will be recruited for this study. the following criteria will be met for inclusion of ad subjects in this study:
boolean
C0002395 (UMLS CUI [1])
age
Item
the participant is 50 years or older.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
written informed consent is obtained.
boolean
C0021430 (UMLS CUI [1])
alzheimers disease; NINCDS-ADRDA Criteria
Item
participants have a clinical diagnosis of alzheimer's disease based on national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association (nincds/adrda) criteria.
boolean
C0002395 (UMLS CUI [1])
C2828081 (UMLS CUI [2])
mini-mental status exam score
Item
mini-mental status exam score < 25.
boolean
C2225229 (UMLS CUI [1])
hachinski ischemia scale score
Item
modified hachinski ischemia scale score of ≤ 4.
boolean
C0475492 (UMLS CUI [1])
depression scales geriatric
Item
geriatric depression scales (gds) ≤ 10.
boolean
C0679604 (UMLS CUI [1,1])
C1704440 (UMLS CUI [1,2])
contraception status; pregnancy test negative
Item
for females, non-child bearing potential or negative urine or blood pregnancy test on day of 123-i av51 injection.
boolean
C0420837 (UMLS CUI [1])
C0427780 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria
Item
healthy control subjects will be excluded from participation for the following reasons:
boolean
C0680251 (UMLS CUI [1])
psychiatric illness
Item
the subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
boolean
C0004936 (UMLS CUI [1])
Compliance behavior Limited Comorbidity
Item
the subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Compliance behavior Limited Comorbidity gastrointenstinal disease
Item
the subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0017178 (UMLS CUI [1,4])
pregnancy
Item
pregnancy
boolean
C0549206 (UMLS CUI [1])
Exclusion Criteria
Item
alzheimer's subjects will be excluded from participation for the following reasons:
boolean
C0680251 (UMLS CUI [1])
neurodegenerative disease; parkinsons disease; dementia; cerebrovascular disease
Item
the subject has signs or symptoms of another neurodegenerative disease including parkinson's disease, diffuse lewy body dementia, or history of significant cerebrovascular disease.
boolean
C0524851 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
C0007820 (UMLS CUI [4])
psychiatric illness
Item
the subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
boolean
C0004936 (UMLS CUI [1])
Compliance behavior Limited Comorbidity; gastrointestinal surgery
Item
the subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery)
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0524722 (UMLS CUI [2])
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