Clinical trial NCT02273895: The Use of EEG in Alzheimer's Disease, With and Without Scopolamine - A Pilot Study
Official title: Development of a Diagnostic Tool for Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AD
Keywords: Scopolamine, AD, EEG, MCI
Lead sponsor: Mentis Cura
Sponsor class: INDUSTRY
Collaborators: name: Landspitali University Hospital
First posted: 2014-10-24
Enrollment: 29
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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) - 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.

Primary outcomes:
measure: Changes in EEG as a result of scopolamine administration
timeFrame: 1 hr after scopolamine administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Landspitali University Hospital
name: Jón Snædal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. doi: 10.1016/j.clinph.2007.06.018. Epub 2007 Aug 31.
citation: Snaedal J, Johannesson GH, Gudmundsson TE, Gudmundsson S, Pajdak TH, Johnsen K. The use of EEG in Alzheimer's disease, with and without scopolamine - a pilot study. Clin Neurophysiol. 2010 Jun;121(6):836-41. doi: 10.1016/j.clinph.2010.01.008. Epub 2010 Feb 12.