Alzheimer´s Disease Clinical Trial
— CholindexOfficial title:
EEG-cholinergic Index and Its Validation of Clinical Response to Treatment With Cholinesterase Inhibitors
Verified date | August 2018 |
Source | Landspitali University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 218 |
Est. completion date | November 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Mild Cognitive Impairment or mild dementia due to Alzheimer´s disease or with dementia due to Lewy body disease. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Landspitali University Hospital | Mentis Cura |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Baseline, 3 months, 6 months | |
Secondary | Mini Mental State Examination (MMSE) | MMSE will be used before initiating treatment (baseline), after 3 months and after 6 months | Baseline, 3 months, 6 months | |
Secondary | CERAD-10 word test | CERAD-10 word test will be used before initiating treatment (baseline) after 3 months and 6 months | Baseline, 3 months, 6 months |
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