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Immune repertoire changes in Alzheimer*s disease: a pilot study

Immune repertoire changes in Alzheimer*s disease: a pilot study - Immune repertoire changes in Alzheimer*s disease: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43575
Enrollment
80
Registered
2016-08-31
Start date
2016-09-28
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)