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

Completed

• Conditions: Alzheimer's Disease; 10012272

• Registration Number: NL-OMON43575
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of the study is the anti-tau immune response, which is<br /><br>divided into: 1) the total concentration of anti-(phospho-)tau antibodies in<br /><br>plasma and 2) the percentage of total peripheral (blood) B lymphocytes reactive<br /><br>against tau, phosphorylated tau, tau oligomers and paired helical filament tau.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes of the study are:<br /><br>1. The (phospho-)tau concentration in plasma, platelets, or plasma exosomes<br /><br>2. The concentration of other proteins or (total) Ig in plasma, platelets, or<br /><br>plasma exosomes for purpose of sample normalization</p><br>