Alzheimer's Disease
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Group 1: Alzheimer*s Disease - Diagnosis of AD according to the NIA-AA criteria (McKhann 2011) - MMSE score of 18-*27 - Have abnormal CSF *-amyloid concentration and/or *-amyloid PET evidence for AD pathology - *50 years old;Group 2: Subjective Cognitive Decline - No objective memory loss with normal results on neuropsychological tests and no other explanation for memory complaints. - MMSE score of 27-30 - Normal CSF *-amyloid concentrations or *-amyloid PET imaging - *50 years old;Group 3: Young healthy controls - No memory complaints - MMSE score of 27-30 - 18-30 years of age
Exclusion criteria
Exclusion criteria: All groups - History of concussion or other acute head trauma in the past six months - Currently engaging in activity (e.g. rugby) likely to induce repetitive head trauma - Stroke or other ischemic incident within 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) - 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 NSAIDs. - Current or previous (within the past year) treatment for malignancy - Current or previous diagnosis of hematological malignancy - Recent transfusion or treatment with blood products such as IVIG - Diagnosis of HIV, HBV, or HCV - Judged not to be of sound mind and judgement;Additional exclusion criteria per research group: Group 1: - Any current medical or neurological condition other than AD that could explain the patient*s dementia - Diagnosis of genetically proven familial AD;Groups 2 and 3: - Current diagnosis of probable dementia of any etiology - Current diagnosis of probable tauopathy of any etiology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the anti-tau immune response, which is divided into: 1) the total concentration of anti-(phospho-)tau antibodies in plasma and 2) the percentage of total peripheral (blood) B lymphocytes reactive against tau, phosphorylated tau, tau oligomers and paired helical filament tau. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes of the study are: 1. The (phospho-)tau concentration in plasma, platelets, or plasma exosomes 2. The concentration of other proteins or (total) Ig in plasma, platelets, or plasma exosomes for purpose of sample normalization | — |
Countries
Netherlands