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

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Scopolamine

About this trial

This is an interventional diagnostic trial for AD focused on measuring Scopolamine, AD, EEG, MCI

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Control

MCI

Arm Description

Scopolamine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02273895

First Posted

September 29, 2014

Last Updated

October 22, 2014

Sponsor

Mentis Cura

Collaborators

Landspitali University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02273895

Brief Title

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

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

October 2004 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mentis Cura

Collaborators

Landspitali University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keywords

Scopolamine, AD, EEG, MCI

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Scopolamine

Arm Title

MCI

Arm Type

Active Comparator

Arm Description

Scopolamine

Arm Title

Arm Type

Active Comparator

Arm Description

Scopolamine

Intervention Type

Drug

Intervention Name(s)

Scopolamine

Other Intervention Name(s)

Scopolamine hydrobromide

Intervention Description

0.3 mg/mL, intravenously, once

Primary Outcome Measure Information:

Title

Changes in EEG as a result of scopolamine administration

Description

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.

Time Frame

1 hr after scopolamine administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jón Snædal, MD

Organizational Affiliation

Landspitali University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

17765604

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.

Results Reference

background

PubMed Identifier

20153691

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.

Results Reference

result

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

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