Description:

ODM derived from http://clinicaltrials.gov/show/NCT00750282

Link:

http://clinicaltrials.gov/show/NCT00750282

Keywords:
Versions (3) ▾
  1. 12/6/13
  2. 4/16/14
  3. 9/20/21
Uploaded on:

September 20, 2021

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT00750282 Alzheimer Disease

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Age at least 55 Years
Is a man or woman and is > 55 of age, whereby females must be without childbearing potential (confirmed by either: age >/= 60. Or history of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start)
Has at least 6 years of education
Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and to comply with study procedures
Possesses a general health that permits adequate compliance with all study procedures
The subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study
Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients)
Healthy Subject
Has no evidence of cognitive impairment
Has MRI brain scan that has been judged as normal (age-appropriate)
Alzheimer's Disease
Presents with positive assessment for dementia of Alzheimer's type
Does not fulfill the criteria DLB or VaD
MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease
Has a caregiver that is willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver
Exclusion Criteria
Has any contraindication to MRI examination scan
Is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application
Is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)
is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable
Has a history of exposure to any radiation >15 mSv/year (e.g. occupational or radiation therapy)
Is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
Has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical
Has a brain tumor or other intracranial lesion, a disturbance of CSF circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery
Has an inflammatory or infectious CNS disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeldt-Jacob disease
Has a history, physical, laboratory or imaging findings indicative of a neurological or psychiatric illness
Has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
Has a history of alcohol or drug abuse
Has history of severe persistent depression

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