Alzheimer´s DiseaseCholindexNCT02623764
EEG-cholinergic Index and Clinical Response to Treatment With Cholinesterase Inhibitors
An observational study of Alzheimer´s Disease, run by Landspitali University Hospital.
Trial summary
Drug treatment with cholinesterase inhibitors is indicated for treatment of Alzheimer´s disease and in most cases, one of these drugs is prescribed as soon as the diagnosis has been made. Nevertheless, it has been shown in several studies that up to 30% of patients do not benefit from treatment. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer´s Disease
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Nov 2019
- Phase
- Observational
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals diagnosed at a Memory Clinic with Mild Cognitive Impairment or mild dementia due to Alzheimer´s disease or with dementia due to Lewy body disease
Who may be able to join
- Mild Cognitive Impairment or mild dementia due to Alzheimer´s disease or with dementia due to Lewy body disease.
Who cannot join
- Too advanced dementia (5 or more on Global Deterioration Scale)
- likelihood of poor compliance due to social circumstances, drug or alcohol abuse or other defined causes.
About this study
Official title: EEG-cholinergic Index and Its Validation of Clinical Response to Treatment With Cholinesterase Inhibitors
Drug treatment with cholinesterase inhibitors is indicated for treatment of Alzheimer´s disease and in most cases, one of these drugs is prescribed as soon as the diagnosis has been made. Nevertheless, it has been shown in several studies that up to 30% of patients do not benefit from treatment. These drugs can have side effects, most frequently from the gastrointestinal tract with nausea, diarrhea and discomfort in the abdomen as the most frequent signs. It is therefore important to know before the treatment is initiated if the patient will likely benefit from the drug or not. It is not possible today with current knowledge but this project aims to evaluate a specific index, calculated from an EEG registration (the EEG-cholinergic index) for this purpose. A conventional EEG registration is done before treatment and the cholinergic index calculated from the EEG registration is compared to the clinical outcome. The duration of follow up is 6 months with an extension of further 6 months.
Read the detailed description
Patients will be recruited in a Memory Clinic. Three possible groups of participants will be offered participation:
- Those with Mild Cognitive Impairment (MCI) but with biomarkers of Alzheimer´s disease (AD) that are conclusive enough to lead to the diagnosis of AD and to initiate medical treatment.
- Those with early dementia of AD that are offered medical treatment and are able to give consent.
- Those with early dementia of Lewy body dementia or Parkinson dementia that are offered medical treatment.
All eligible participants are evaluated by the Mini Mental State Examination (MMSE), Consortium to Establish Registry in Alzheimer´s Disease (CERAD 10 word test; working memory, delayed memory and recognition) and Clock Drawing Test (CDT). In addition, the Addenbrooke test will be used.
Patients with AD irrespective of stage will be offered treatment with donepezil, the most used and cheapest cholinesterase inhibitor in Iceland. The dosis will be as usual, 5mg in the evening for four weeks, then increased to 10mg in the evening.
Patients with Lewy body dementia and Parkinson dementia are offered rivastigmine in patch as this is the only medication with the indication of cognitive impairment in these disorders. The starting dose is 4.6mg/day increased to 9.5mg/day after 4 weeks.
After 3 months, each participant is evaluated again with the same tests as before initiating treatment (continuous variables). The clinical effect is also rated according to Clinical Dementia Rating (CDR; categorical variables). An EEG registration is performed. Adherence to drug therapy as well as evaluation of side effects is registrated.
After 6 months, each participant is evaluated again as after 3 months. This is the primary end point.
After 12 months an additional evaluation is performed by the same instruments (secondary endpoint).
The EEG is thus registrated 3 times (primary end point) or 4 times (secondary end point as the first registration was done during the diagnostic work up before entering the project. The EEG will reveal group wise category (Normal, AD or Lewy according to the third edition (SIGLA) of Mentis Cura). An analysis of the cholinergic index is not revealed to the clinician that is thus blinded to this part of the EEG analysis.
The project will be analysed based on all available information after primary end point. A second analysis will be performed after the second end point.
- Conditions
- Alzheimer´s Disease
- Keywords
- Alzheimer´s disease, Lewy body dementia, Parkinson dementia, EEG, Cholinergic index
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MCI due to Alzheimer´s disease | Individuals with MCI diagnosed with Alzheimer´s disease on the basis of cognitive decline and positive biomarkers by MRI and/or Cerebro Spinal Fluid (CSF) analysis. The intervention is donepezil in recommended doses, 5mg/day for a month and then 10mg/day. Cholinergic index in EEG will be measured before initiating treatment, after 3 and 6 months and related to clinical response of treatment | |
| Mild dementia due to Alzheimer´s disease | Individuals with mild dementia and diagnosed with Alzheimer´s disease on the basis of cognitive decline and positive biomarkers by MRI and/or CSF analysis. The intervention is donepezil in recommended doses, 5mg/day for a month and then 10mg/day. Cholinergic index in EEG will be measured before initiating treatment, after 3 and 6 months and related to clinical response of treatment | |
| Mild dementia due to Lewy body disease | Individuals with mild Lewy body dementia. The intervention is Exelon patches in recommended doses, 4.6mg/day for a month and then 9.5mg/day. Cholinergic index in EEG will be measured before initiating treatment, after 3 and 6 months and related to clinical response of treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Addenbrooke cognitive battery at 3 months and at 6 months
Addenbrooke cognitive battery will be used before initiating treatment (baseline), after 3 months and after 6 months
Measured: Baseline, 3 months, 6 months
Secondary outcomes (2)
Mini Mental State Examination (MMSE)
MMSE will be used before initiating treatment (baseline), after 3 months and after 6 months
Measured: Baseline, 3 months, 6 months
CERAD-10 word test
CERAD-10 word test will be used before initiating treatment (baseline) after 3 months and 6 months
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMay 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer´s DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landspitali University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mentis Cura
- Responsible party
- Sponsor
- Investigators
- Jon Snaedal, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623764
- Sponsor's protocol ID
- LSH-15-002
- Acronym
- Cholindex
- Status last verified
- Aug 2018
- First submitted
- 5 Nov 2015
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG-cholinergic Index and Its Validation of Clinical Response to Treatment With Cholinesterase Inhibitors
- ClinicalTrials.gov ID
- NCT02623764
- Acronym / sponsor ID
- Cholindex / LSH-15-002
- Conditions
- Alzheimer´s Disease
- Keywords
- Alzheimer´s disease, Lewy body dementia, Parkinson dementia, EEG, Cholinergic index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Landspitali University HospitalUniversity, hospital or other
- Collaborators
- Mentis Cura
- Study start
- Dec 2015
- Primary completion
- May 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 8 Dec 2015 (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.
Drug treatment with cholinesterase inhibitors is indicated for treatment of Alzheimer´s disease and in most cases, one of these drugs is prescribed as soon as the diagnosis has been made. Nevertheless, it has been shown in several studies that up to 30% of patients do not benefit from treatment. These drugs can have side effects, most frequently from the gastrointestinal tract with nausea, diarrhea and discomfort in the abdomen as the most frequent signs. It is therefore important to know before the treatment is initiated if the patient will likely benefit from the drug or not. It is not possible today with current knowledge but this project aims to evaluate a specific index, calculated from an EEG registration (the EEG-cholinergic index) for this purpose. A conventional EEG registration is done before treatment and the cholinergic index calculated from the EEG registration is compared to the clinical outcome. The duration of follow up is 6 months with an extension of further 6 months.
Detailed description
Patients will be recruited in a Memory Clinic. Three possible groups of participants will be offered participation:
- Those with Mild Cognitive Impairment (MCI) but with biomarkers of Alzheimer´s disease (AD) that are conclusive enough to lead to the diagnosis of AD and to initiate medical treatment.
- Those with early dementia of AD that are offered medical treatment and are able to give consent.
- Those with early dementia of Lewy body dementia or Parkinson dementia that are offered medical treatment.
All eligible participants are evaluated by the Mini Mental State Examination (MMSE), Consortium to Establish Registry in Alzheimer´s Disease (CERAD 10 word test; working memory, delayed memory and recognition) and Clock Drawing Test (CDT). In addition, the Addenbrooke test will be used.
Patients with AD irrespective of stage will be offered treatment with donepezil, the most used and cheapest cholinesterase inhibitor in Iceland. The dosis will be as usual, 5mg in the evening for four weeks, then increased to 10mg in the evening.
Patients with Lewy body dementia and Parkinson dementia are offered rivastigmine in patch as this is the only medication with the indication of cognitive impairment in these disorders. The starting dose is 4.6mg/day increased to 9.5mg/day after 4 weeks.
After 3 months, each participant is evaluated again with the same tests as before initiating treatment (continuous variables). The clinical effect is also rated according to Clinical Dementia Rating (CDR; categorical variables). An EEG registration is performed. Adherence to drug therapy as well as evaluation of side effects is registrated.
After 6 months, each participant is evaluated again as after 3 months. This is the primary end point.
After 12 months an additional evaluation is performed by the same instruments (secondary endpoint).
The EEG is thus registrated 3 times (primary end point) or 4 times (secondary end point as the first registration was done during the diagnostic work up before entering the project. The EEG will reveal group wise category (Normal, AD or Lewy according to the third edition (SIGLA) of Mentis Cura). An analysis of the cholinergic index is not revealed to the clinician that is thus blinded to this part of the EEG analysis.
The project will be analysed based on all available information after primary end point. A second analysis will be performed after the second end point.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MCI due to Alzheimer´s disease | – | –Individuals with MCI diagnosed with Alzheimer´s disease on the basis of cognitive decline and positive biomarkers by MRI and/or Cerebro Spinal Fluid (CSF) analysis. The intervention is donepezil in recommended doses, 5mg/day for a month and then 10mg/day. Cholinergic index in EEG will be measured before initiating treatment, after 3 and 6 months and related to clinical response of treatment |
| Mild dementia due to Alzheimer´s disease | – | –Individuals with mild dementia and diagnosed with Alzheimer´s disease on the basis of cognitive decline and positive biomarkers by MRI and/or CSF analysis. The intervention is donepezil in recommended doses, 5mg/day for a month and then 10mg/day. Cholinergic index in EEG will be measured before initiating treatment, after 3 and 6 months and related to clinical response of treatment |
| Mild dementia due to Lewy body disease | – | –Individuals with mild Lewy body dementia. The intervention is Exelon patches in recommended doses, 4.6mg/day for a month and then 9.5mg/day. Cholinergic index in EEG will be measured before initiating treatment, after 3 and 6 months and related to clinical response of treatment |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed at a Memory Clinic with Mild Cognitive Impairment or mild dementia due to Alzheimer´s disease or with dementia due to Lewy body disease
Key inclusion criteria (1 listed)
- Mild Cognitive Impairment or mild dementia due to Alzheimer´s disease or with dementia due to Lewy body disease.
Key exclusion criteria (2 listed)
- Too advanced dementia (5 or more on Global Deterioration Scale)
- likelihood of poor compliance due to social circumstances, drug or alcohol abuse or other defined causes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in Addenbrooke cognitive battery at 3 months and at 6 months
Time frame: Baseline, 3 months, 6 months
Addenbrooke cognitive battery will be used before initiating treatment (baseline), after 3 months and after 6 months
2 secondary outcomes
Mini Mental State Examination (MMSE)
Time frame: Baseline, 3 months, 6 months
CERAD-10 word test
Time frame: Baseline, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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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.
Jon Snaedal, MD principal investigator
Professor
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer´s Disease, run by Landspitali University Hospital.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Aug 2018. 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?
Results are not available in the source record.
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?
Change from baseline in Addenbrooke cognitive battery at 3 months and at 6 months (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2018.