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Completed

NCT Number: NCT02273895

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

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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Key information

Conditions

AD

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scopolamine

Drug

0.3 mg/mL, intravenously, once

Other names: Scopolamine hydrobromide

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mentis Cura

Industry

Collaborators

  • Landspitali University Hospital

Registry information

Official study title

Development of a Diagnostic Tool for Alzheimer's Disease

Important dates

Study start
2004
Primary completion
2004
Study completion
2010
First posted
Oct 24, 2014
Registry last updated
Oct 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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