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

AD Clinical Trial

Official title:

Development of a Diagnostic Tool for Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273895
• Other study ID #: MC-CT-001
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: October 22, 2014
• Start date: April 2004
• Est. completion date: January 2010

Study information

• Verified date: October 2014
• Source: Mentis Cura
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iceland: Icelandic Medicines Control AgencyIceland: Ministry of Health and Social SecurityIceland: Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2010
• Est. primary completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• AD
• Alzheimer Disease

Intervention

Drug:
• Scopolamine
0.3 mg/mL, intravenously, once

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mentis Cura	Landspitali University Hospital

References & Publications (2)

Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. Epub 2007 Aug 31. — View 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 Fe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in EEG as a result of 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.	1 hr after scopolamine administration	No