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

Not Applicable

Completed

• Conditions: AD
• Interventions: Drug: Scopolamine

• Registration Number: NCT02273895
• Lead Sponsor: Mentis Cura

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2004-10
• Study Completion: 2010-01
• Study First Submitted: 2014-09-29
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-22
• Last Update Submitted: 2014-10-22
• Study First Posted: 2014-10-24
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Scopolamine	Scopolamine
MCI	Scopolamine	Scopolamine
AD	Scopolamine	Scopolamine

Primary Outcome Measures

Name	Time	Method
Changes in EEG as a result of scopolamine administration	1 hr after 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.