Eligibility Age Related Cognitive Decline NCT01953705

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StudyEvent: Eligibility
1. Eligibility Age Related Cognitive Decline NCT01953705

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

cognitive impairment

Item

non-demented or mild cognitive impairment, defined as clinical dementia rating =0 or 0.5.

boolean

C0338656 (UMLS CUI [1])

age, sex

Item

age 80 and older, male and female

boolean

C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])

wmh volume

Item

total wmh volume ≥ 6 cc (>80% of our oregon brain aging study population meets this criterion)

boolean

C0682708 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])

plasma pufa

Item

plasma pufa (epa + dha) < 110 ug/ml or < 5 weight percent (>85% of our obas population meets this)

boolean

C0032615 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])

english language skills

Item

sufficient english language skills to complete all tests

boolean

C0376245 (UMLS CUI [1])

geriatric depression scale

Item

geriatric depression scale - 15 < 6 documenting absence of a significant depressive syndrome

boolean

C0451184 (UMLS CUI [1])

vision and hearing

Item

sufficient vision and hearing to complete all tests

boolean

C2706921 (UMLS CUI [1])

functional status

Item

informant available with frequent (at least 1 hour/day or 1 day/week) contact with subject to verify functional status and cdr rating

boolean

C0598463 (UMLS CUI [1])

health status

Item

general health status that will not interfere with the ability to complete the prospective study (these conditions are listed below in the study exclusion list)

boolean

C0018759 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

dementing illness

Item

any dementing illness (ad, vascular dementia, normal pressure hydrocephalus, or parkinson's disease); dementia defined by cdr ≥ 1

boolean

C0497327 (UMLS CUI [1])

cns disease

Item

significant disease of the cns such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis

boolean

C0007682 (UMLS CUI [1])

substance abuse

Item

alcohol or substance abuse according to dsm-iv criteria within the last 2 years

boolean

C0038586 (UMLS CUI [1])

psychiatric disorder

Item

major depression, schizophrenia, or other major psychiatric disorder defined by dsm-iv criteria

boolean

C0004936 (UMLS CUI [1])

b12 deficiency

Item

abnormal labs indicating vitamin b12 deficiency, thyroid disease, or uti (documented bacterial colonization is acceptable)

boolean

C0042847 (UMLS CUI [1])

cvd

Item

unstable or significantly symptomatic cvd (e.g. cad with frequent angina, chf with dyspnea at rest)

boolean

C0007222 (UMLS CUI [1])

hypertension

Item

hypertension: either 1) blood pressure > 150/90 or 2) > 2 medications to control

boolean

C0020538 (UMLS CUI [1])

orthostatic hypotension

Item

clinical symptomatic orthostatic hypotension

boolean

C0020651 (UMLS CUI [1])

diabetes mellitus

Item

diabetes mellitus that requires insulin injections

boolean

C0011849 (UMLS CUI [1])

cortical stroke

Item

history of cortical stroke

boolean

C0038454 (UMLS CUI [1])

cancer

Item

cancer within the last 5 years, with the exception of localized prostate cancer (gleason grade < 3) and non-metastatic skin cancers (melanoma).

boolean

C0006826 (UMLS CUI [1])

illness

Item

illness that requires >1 visit /month to a clinician

boolean

C0221423 (UMLS CUI [1])

vision loss

Item

progressive vision loss (age-related macular degeneration already beginning to degrade vision)

boolean

C3665347 (UMLS CUI [1])

contraindications to mri

Item

contraindications to mri (i.e., heart pacemaker, metal plates or objects in head, metal worker)

boolean

C0079164 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])

analgesics

Item

analgesics: frequent use of high doses

boolean

C0002771 (UMLS CUI [1])

sedatives

Item

sedatives: except for those used occasionally for sleep (use limited to ≤ twice per week)

boolean

C0036557 (UMLS CUI [1])

cns active meds

Item

cns active meds that have not been on stable doses for at least 2 months (cimetidine, beta-blockers, and ssris)

boolean

C1874882 (UMLS CUI [1])

active hypertension

Item

active hypertension on > 2 meds or using cns active agents (propranolol or clonidine)

boolean

C0020538 (UMLS CUI [1])

neuroleptics

Item

neuroleptics, antiparkinsonian agents, systemic corticosteroids, and narcotic analgesics; in the case where these were used for a self-limited time they must have been discounted for a period of five half-lives prior to baseline visit

boolean

C0040615 (UMLS CUI [1])

supplements

Item

over the counter supplements are not by themselves exclusionary, however, subjects are asked not to change the dosing regimen over the course of the trial unless medically indicated; the presence and dose of these agents are recorded

boolean

C0242295 (UMLS CUI [1])

omega 3

Item

taking omega 3 pufa supplements and a screen plasma pufa > 5 weight percent of total fatty acids for epa+dha will confirm supplementation of o3pufa history

boolean

C0015689 (UMLS CUI [1])

cholinesterase inhibitor

Item

cholinesterase inhibitors (i.e., aricept)

boolean

C0008425 (UMLS CUI [1])

investigational drug

Item

investigational drugs within five half-lives prior to baseline

boolean

C0013230 (UMLS CUI [1])

anticoagulation therapy

Item

anticoagulation therapy: vitamin k agonist, warfarin, factor xa inhibitors, low molecular weight heparins.

boolean

C0003281 (UMLS CUI [1])

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Eligibility Age Related Cognitive Decline NCT01953705