NCT02273895

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

September 29, 2014

Last Update Submit

October 22, 2014

Conditions

AD

Keywords

Scopolamine, AD, EEG, MCI

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Control

ACTIVE COMPARATOR

Scopolamine

Drug: Scopolamine

MCI

ACTIVE COMPARATOR

Scopolamine

Drug: Scopolamine

AD

ACTIVE COMPARATOR

Scopolamine

Drug: Scopolamine

Interventions

ScopolamineDRUG

0.3 mg/mL, intravenously, once

Also known as: Scopolamine hydrobromide
ADControlMCI

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1016/j.clinph.2007.06.018. Epub 2007 Aug 31.

    PMID: 17765604BACKGROUND

  • 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.

    PMID: 20153691RESULT

MeSH Terms

Interventions

Scopolamine

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Jón Snædal, MD

    Landspitali University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 24, 2014

Study Start

April 1, 2004

Primary Completion

October 1, 2004

Study Completion

January 1, 2010

Last Updated

October 24, 2014

Record last verified: 2014-10