Development of a Diagnostic Tool for Alzheimer's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 29
- Primary Endpoint
- Changes in EEG as a result of scopolamine administration
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- 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) -
- •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.
Arms & Interventions
Control
Scopolamine
Intervention: Scopolamine (Drug)
MCI
Scopolamine
Intervention: Scopolamine (Drug)
AD
Scopolamine
Intervention: Scopolamine (Drug)
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.
Secondary Outcomes
No secondary outcomes reported