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

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ClinicalTrials.gov Identifier: NCT02273895
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Collaborator:
Landspitali University Hospital
Information provided by (Responsible Party):
Mentis Cura

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
AD Drug: Scopolamine Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : April 2004
Actual Primary Completion Date : October 2004
Actual Study Completion Date : January 2010


Arm Intervention/treatment
Active Comparator: Control
Scopolamine
Drug: Scopolamine
0.3 mg/mL, intravenously, once
Other Name: Scopolamine hydrobromide

Active Comparator: MCI
Scopolamine
Drug: Scopolamine
0.3 mg/mL, intravenously, once
Other Name: Scopolamine hydrobromide

Active Comparator: AD
Scopolamine
Drug: Scopolamine
0.3 mg/mL, intravenously, once
Other Name: Scopolamine hydrobromide




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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) - 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273895


Sponsors and Collaborators
Mentis Cura
Landspitali University Hospital
Investigators
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Principal Investigator: Jón Snædal, MD Landspitali University Hospital

Publications of Results:
Other Publications:
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Responsible Party: Mentis Cura
ClinicalTrials.gov Identifier: NCT02273895    
Other Study ID Numbers: MC-CT-001
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Keywords provided by Mentis Cura:
Scopolamine, AD, EEG, MCI
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Scopolamine
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics