The Use of EEG in Alzheimer's Disease, With and Without Scopolamine - A Pilot Study

Study Overview
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Brief Summary
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The objective of this study is to compare the electroencephalography (EEG) responses of three distinct groups of individuals to scopolamine: 1) a group of Alzheimer Dementia (AD) patients, 2) a group of individuals suffering from Mild Cognitive Impairment (MCI) and 3) a group of controls. The main purpose of this comparison is to discover ways to use these responses to distinguish between the group of AD patients and controls in order to develop a diagnostic tool for AD. The purpose of including the MCI group is to investigate whether this diagnostic tool can predict which member of the MCI group will develop AD later in life.

Official Title
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Development of a Diagnostic Tool for Alzheimer's Disease

Conditions
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AD

Intervention / Treatment
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* Drug: Scopolamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects: Between 60-80 years of age. Volunteers will have to be in good general health as determined by standard physical examination. Normal Electrocardiograph (ECG) MCI subjects: Diagnosed with MCI at the Memory Clinic at the Landspitali University Hospital using F 06,7 according to International Classification of Diseases (ICD) - 10. Between 60-80 years of age. Subjects need to score between 2 and 3 on the Global Deterioration Scale (GDS). Normal ECG Alzheimer's patients: Diagnosed with AD according to ICD - 10 in Follow up at the Memory Clinic at the Landspitali University Hospital. Between 60-80 years of age. Subjects need to score between 3-5 on the GDS. Normal ECG Treated with Reminyl® for the Alzheimer disease. Exclusion Criteria: Smoking or any other use of tobacco. Taking neuroleptics or benzodiazepines (allowed to take oxazepam ad vesp). Neurological-, cardiovascular-, gastrointestinal- or genitourinary disorders of medical importance. Glaucoma or history of possibly raised intraocular pressure. Impaired liver- or kidney function. Hypersensitivity to Scopolamine or any component in the formulation. Any indication of drug, alcohol or medicine abuse. Participation in another investigational study at the same time.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Scopolamine | Drug: Scopolamine<br>* 0.3 mg/mL, intravenously, once<br>* Other names: Scopolamine hydrobromide;|
| Active Comparator: MCI<br>Scopolamine | Drug: Scopolamine<br>* 0.3 mg/mL, intravenously, once<br>* Other names: Scopolamine hydrobromide;|
| Active Comparator: AD<br>Scopolamine | Drug: Scopolamine<br>* 0.3 mg/mL, intravenously, once<br>* Other names: Scopolamine hydrobromide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in EEG as a result of scopolamine administration | The EEG is recorded before, during and after scopolamine administration in order to monitor the effects scopolamine has on the brain as measured by EEG. | 1 hr after scopolamine administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scopolamine, AD, EEG, MCI