ADNCT02273895
The Use of EEG in Alzheimer's Disease, With and Without Scopolamine - A Pilot Study
A study testing Scopolamine in people with AD, run by Mentis Cura.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- AD
- What is being tested?
- Scopolamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
About this study
Official title: Development of a Diagnostic Tool for Alzheimer's Disease
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.
- Conditions
- AD
- Being tested
- Scopolamine
- Keywords
- Scopolamine, AD, EEG, MCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScopolamineDrug
Also called Scopolamine hydrobromide
0.3 mg/mL, intravenously, once
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Scopolamine Receives: Drug: Scopolamine |
| MCI | Active comparator | Scopolamine Receives: Drug: Scopolamine |
| AD | Active comparator | Scopolamine Receives: Drug: Scopolamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hr after scopolamine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startApr 2004
- Primary completionOct 2004
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mentis Cura
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital
- Responsible party
- Sponsor
- Investigators
- Jón Snædal, MD, Principal investigator, Landspitali University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273895
- Sponsor's protocol ID
- MC-CT-001
- Status last verified
- Oct 2014
- First submitted
- 29 Sep 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17765604Snaedal 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.
PubMed 20153691
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Diagnostic Tool for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02273895
- Acronym / sponsor ID
- MC-CT-001
- Conditions
- AD
- Keywords
- Scopolamine, AD, EEG, MCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mentis CuraIndustry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital
- Study start
- Apr 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: ScopolamineScopolamine |
| MCI | Active comparator | Drug: ScopolamineScopolamine |
| AD | Active comparator | Drug: ScopolamineScopolamine |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Between 60-80 years of age.
- Volunteers will have to be in good general health as determined by standard physical examination.
- Normal Electrocardiograph (ECG)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScopolamineAlso: Scopolamine hydrobromide0.3 mg/mL, intravenously, once | Drug | AD, Control, MCI |
Primary outcome
Changes in EEG as a result of scopolamine administration
Time frame: 1 hr after 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
- Background: PubMed 17765604Gudmundsson 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 publication: PubMed 20153691Snaedal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jón Snædal, MD principal investigator
Landspitali University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Scopolamine in people with AD, run by Mentis Cura.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in EEG as a result of scopolamine administration (time frame: 1 hr after scopolamine administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02273895, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2014.