EEG-cholinergic Index and Clinical Response to Treatment With Cholinesterase Inhibitors

NCT02623764 | Unknown DMC

• 1 other identifier: LSH-15-002
• Study Type: observational
• Target: 218
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Alzheimer´s Disease

Keywords

Alzheimer´s disease; Lewy body dementia; Parkinson dementia; EEG; Cholinergic index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mini Mental State Examination (MMSE)

  Baseline, 3 months, 6 months

• CERAD-10 word test

  Baseline, 3 months, 6 months

Study Arms (3)

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

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Mild Cognitive Impairment or mild dementia due to Alzheimer´s disease or with dementia due to Lewy body disease.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Landspitali University Hospital: lead
• Mentis Cura: collaborator

MeSH Terms

Conditions

Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jon Snaedal, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: December 8, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 17, 2018

Record last verified: 2018-08