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

Sponsor
Mentis Cura (Industry)
Overall Status
Completed
CT.gov ID
NCT02273895
Collaborator
Landspitali University Hospital (Other)
29
Enrollment
3
Arms
69
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Development of a Diagnostic Tool for Alzheimer's Disease
Study Start Date :
Apr 1, 2004
Actual Primary Completion Date :
Oct 1, 2004
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mentis Cura
    • Landspitali University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mentis Cura
    ClinicalTrials.gov Identifier:
    NCT02273895
    Other Study ID Numbers:
    • MC-CT-001
    First Posted:
    Oct 24, 2014
    Last Update Posted:
    Oct 24, 2014
    Last Verified:
    Oct 1, 2014
    Keywords provided by Mentis Cura
    Scopolamine, AD, EEG, MCI
    Additional relevant MeSH terms:
    Alzheimer Disease
    Scopolamine
    Butylscopolammonium Bromide

    Study Results

    No Results Posted as of Oct 24, 2014