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

October 22, 2014 updated by: Mentis Cura

Development of a Diagnostic Tool for Alzheimer's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Scopolamine
Drug: Scopolamine
0.3 mg/mL, intravenously, once
Other Names:
  • Scopolamine hydrobromide
Active Comparator: MCI
Scopolamine
Drug: Scopolamine
0.3 mg/mL, intravenously, once
Other Names:
  • Scopolamine hydrobromide
Active Comparator: AD
Scopolamine
Drug: Scopolamine
0.3 mg/mL, intravenously, once
Other Names:
  • Scopolamine hydrobromide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in EEG as a result of scopolamine administration
Time Frame: 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.
1 hr after scopolamine administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mentis Cura

Collaborators

Landspitali University Hospital

Investigators

  • Principal Investigator: Jón Snædal, MD, Landspitali University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Estimate)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 22, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC-CT-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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