Evaluating blood biomarkers from healthy controls and patients with age*related disease: Alzheimer*s disease

Completed

• Conditions: eurodegenerative disorders; Alzheimer's disease; dementia

• Registration Number: NL-OMON44366
• Lead Sponsor: Johnson & Johnson Pharmaceutical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

- Written informed consent
- Able to communicate well with the investigator in the Dutch language
- Aged 65-85 (including 85) years.;Additional for AD patients:
- New diagnosed with probable AD according to NIA-AA criteria
- MMSE score 18-26
- Imaging evidence to confirm absence of cerebrovascular damage or other neurodegenerative disorder
- Mentally competent for study participation as judged by treating physician and study physician.;Additional inclusion criteria for the healthy controls are:
- No memory complaints;
- MMSE score *27;
- 7MS total score < 0 (formula for total score calculation is described in Solomon et al.
1998);
- Considered healthy defined by absence of any active or chronic disease, based on
medical history (self*reported) and physical examination.

Exclusion Criteria

Exclusion criteria for AD subjects are:
- Diagnosis of genetically proven familial AD
- History of concussion or other acute head trauma in the past six months;
- Current or past diagnosis of autoimmune disease;
- Current or past diagnosis of immunosuppressive disorder;
- Ongoing or past (within the last 3 months) treatment with any immunosuppressive
drug (e.g. prednisone);
- Recent (within the last 3 months) transfusion or treatment with blood products such
as intravenous immunoglobulins;
- Ongoing or past (within the last 3 months) treatment with drugs (e.g. Anakinra) that
suppress the interleukin*1, interleukin*6, or TNF** response EXCEPT non*steroidal
anti*inflammatory drugs;
- Current or previous (within the past year) treatment for malignancy;
- Current or previous (within the past year) diagnosis of hematological malignancy;
- Recent (within last 3 months) surgery;
- Recent (within last 2 weeks) acute infection.;Exclusion criteria for healthy elderly:
- Current diagnosis of probable dementia of any etiology;
- Current or past diagnosis of clinically significant pulmonary, cardiovascular,
endocrine, hematologic, neurological, immune, gastrointestinal or genitourinary
disease or cancer;
- Recent (within last 3 months) surgery;
- Recent (within last 2 weeks) acute infection;
- Taking any prescription drugs within 14 days of the study day or within 5 times the
elimination half*life of the medication (whichever is longer). Occasional
acetaminophen/paracetamol use and statins (if given as primary prevention) are
allowed. Exceptions may apply when, judged by the investigator, use of concomitant
medication does not interfere with the study objectives.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints of this study are A*1*42/A*1*40 ratio, A*1*40, A*1*42,<br /><br>NFL, t*tau and anti*tau antibodies in plasma</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint is the combination of biological age with AD markers.<br /><br>Biological age will be calculated using measurements of FEV1, systolic blood<br /><br>pressure, total cholesterol, C*reactive protein, cytomegalovirus IgG,<br /><br>creatinine, urea nitrogen, alkaline phosphatase, albumin and glycated<br /><br>haemoglobin.</p><br>