The Use of EEG in Alzheimer's Disease, With and Without Scopolamine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2010-01-31

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.

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Detailed Description

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Conditions

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AD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control

Scopolamine

Group Type ACTIVE_COMPARATOR

Scopolamine

Intervention Type DRUG

0.3 mg/mL, intravenously, once

MCI

Scopolamine

Group Type ACTIVE_COMPARATOR

Scopolamine

Intervention Type DRUG

0.3 mg/mL, intravenously, once

AD

Scopolamine

Group Type ACTIVE_COMPARATOR

Scopolamine

Intervention Type DRUG

0.3 mg/mL, intravenously, once

Interventions

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Scopolamine

0.3 mg/mL, intravenously, once

Intervention Type DRUG

Other Intervention Names

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Scopolamine hydrobromide

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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes