Neurodegenerative disorders Alzheimer's disease dementia
Conditions
Interventions
None listed
Sponsors
Johnson & Johnson Pharmaceutical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of this study are A*1*42/A*1*40 ratio, A*1*40, A*1*42, NFL, t*tau and anti*tau antibodies in plasma | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the combination of biological age with AD markers. Biological age will be calculated using measurements of FEV1, systolic blood pressure, total cholesterol, C*reactive protein, cytomegalovirus IgG, creatinine, urea nitrogen, alkaline phosphatase, albumin and glycated haemoglobin. | — |
Countries
Netherlands
Outcome results
None listed