Correlation Between Melatonin Levels in Different Biological Fluids

Study Overview
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Brief Summary
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The goal of this observational study is to evaluate and to correlate melatonin levels in plasma, saliva and cerebrospinal fluid (CSF) samples of patients undergoing lumbar puncture diagnostic for specific neurological diseases.

Official Title
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Livelli di Melatonina e Dei Suoi Precursori/Metaboliti in Differenti Fluidi Biologici: vi è Correlazione?

Conditions
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Neurodegenerative Diseases

Intervention / Treatment
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* Other: blood and saliva sample and lumbar puncture diagnostic for specific neurological diseases


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neurodegenerative disease Exclusion Criteria: Age < 18 years Pregnancy Coagulations disorders Anticoagulant therapy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AD<br>Alzheimer's Disease | Other: blood and saliva sample and lumbar puncture diagnostic for specific neurological diseases<br>* Saliva was collected using Salivettes (Sarsted, Newton, NC, USA) in dim light. CSF was obtained in the morning after overnight fasting by lumbar puncture at the L3/L4 or L4/L5 interspace. Blood samples were drawn in fasting conditions. Plasma was separated by centrifugation.<br>|
| NON AD<br>Non Alzheimer's Disease | Other: blood and saliva sample and lumbar puncture diagnostic for specific neurological diseases<br>* Saliva was collected using Salivettes (Sarsted, Newton, NC, USA) in dim light. CSF was obtained in the morning after overnight fasting by lumbar puncture at the L3/L4 or L4/L5 interspace. Blood samples were drawn in fasting conditions. Plasma was separated by centrifugation.<br>|
| CT<br>Controls | Other: blood and saliva sample and lumbar puncture diagnostic for specific neurological diseases<br>* Saliva was collected using Salivettes (Sarsted, Newton, NC, USA) in dim light. CSF was obtained in the morning after overnight fasting by lumbar puncture at the L3/L4 or L4/L5 interspace. Blood samples were drawn in fasting conditions. Plasma was separated by centrifugation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melatonin levels in saliva | Analysis of melatonin levels by ELISA kit. Values expressed in pg/ml | Baseline | 
| Melatonin levels in plasma | Analysis of melatonin levels by ELISA kit. Values expressed in pg/ml | Baseline | 
| Melatonin levels in cerebrospinal fluid | Analysis of melatonin levels by ELISA kit. Values expressed in pg/ml | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orexin levels in cerebrospinal fluid | Analysis of orexin levels by ELISA kit. Values expressed in ng/ml | Baseline | 
| Neurofilaments light chain levels (NFL) in cerebrospinal fluid | Analysis of NFL levels by SIMOA kit. Values expressed in pg/ml | Baseline |