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

Information source: Mentis Cura
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: AD

Intervention: Scopolamine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Mentis Cura

Official(s) and/or principal investigator(s):
Jón Snædal, MD, Principal Investigator, Affiliation: Landspitali University Hospital

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.

Clinical Details

Official title: Development of a Diagnostic Tool for Alzheimer's Disease

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

Primary outcome: Changes in EEG as a result of scopolamine administration

Eligibility

Minimum age: 60 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Related publications:

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.

Starting date: April 2004
Last updated: October 22, 2014

Page last updated: August 23, 2015

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