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Clinical Trials/NCT02273895
NCT02273895
Completed
Not Applicable

Development of a Diagnostic Tool for Alzheimer's Disease

Mentis Cura0 sites29 target enrollmentApril 2004
ConditionsAD
InterventionsScopolamine

Overview

Phase
Not Applicable
Intervention
Scopolamine
Conditions
AD
Sponsor
Mentis Cura
Enrollment
29
Primary Endpoint
Changes in EEG as a result of scopolamine administration
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2004
End Date
January 2010
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mentis Cura
Responsible Party
Sponsor

Eligibility Criteria

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) -
  • 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:

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.

Arms & Interventions

Control

Scopolamine

Intervention: Scopolamine

MCI

Scopolamine

Intervention: Scopolamine

AD

Scopolamine

Intervention: Scopolamine

Outcomes

Primary Outcomes

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.

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