Amnestic Mild cognitive Impairment (aMCI) MedDRA version: 9.1 Level: LLT Classification code 10009846 Term: Cognitive impairment
Conditions
Interventions
Trade Name: Aricept 5mg coated tablets
Product Name: N/A
Product Code: N/A
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: donepezil free base
CAS Number: n/a
Current Sponsor code: n/a
Other d
Sponsors
St James Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Older controls: 1.Aged 55-85 years 2.Absence of symptoms of cognitive impairment 3.MMSE score of 27 or higher 4.Test scores on the neuropsychological battery (see below) that are not more than 1 SD below age-adjusted norms 5.If history of alcohol dependence: abstinent for 10 years prior to study 6.If on antidepressants: mood stable on same dose for 3 months prior to study(bellow cutoff scores on the Hospital Anxiety and Depression Scale) 7.Be MRI compatible as per St James’s Hospital Centre for Advanced Imaging (CAMI)MRI screening form aMCI 1.Aged 55-85 years 2.symptoms of cognitive impairment of at least 6 months 3.the diagnosis of "not demented" (i.e. CDR status of 0 or 0.5) 4.must score greater than 1.5 SD below aged norms on at least one of the following:WMS-111 -logical memory,visual reproduction or face recognition 5.only include as aMCI delayed measures and not immediate measures 6.meet consensus criteria for amnestic MCI (aMCI; Winblad et al,2004) 7.If history of alcohol dependence: abstinent for 10 years prior to onset of memory loss and memory loss not related tot alcohol as judged by investigator. 8.If on antidepressants: mood stable on same dose for 3 months prior to study(below cutoff scores on the Hospital Anxiety and Depression Scale) 9.Be MRI compatible as per St James’s Hospital Centre for Advanced Imaging (CAMI)MRI screening form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Active medical disease or untreated psychiatric disease 2.History of stroke,epilepsy/seizure disorder,heart attack,syncopal,episodes of unexplained loss of consciousness 3.History of head injury where:Post-traumatic amnesia greater than 24 hours, CT evidence of brain injury, clinically significant post-traumatic sequealae as judged by investigator or loss of consciousness for more than 1 hour 4.History of major psychiatric illness excluding controlled depression 5.Currently taking psychotropic medication, benzodiazepines or oral steroids 6.History or presence of drug abuse 7.Current alcohol dependence/abuse 8.Scoring above cut-offs on screening anxiety and depression scales (the Hospital Anxiety and Depression Scale (HADS) depression score >8, anxiety score >8) . 9.If English is not their first language. 10.Any contraindications to taking donepezil as specified in the Summary of Product Characteristics, including history or presence of asthma and seizures. 11.Clinically significant abnormalities on screening ECG, including but not limited to conduction abnormalities or heart rate <55 beats / min as judged by the investigator 12.Clinically significant abnormalities on screening laboratory tests as judged by the investigator 13. Clinically significant chronic obstructive airways disease and peptic ulcer disease as judged by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to define the short term effects of the existing Alzheimer's Disease(AD) symptomatic treatment compound donepezil on cognitive EEG/ERP and fMRI endpoints in normal elderly and amnestic mild cognitive impairment (aMCI) cohorts.The overall goal of the study is to develop EEG/ERP and fMRI measures that can detect pharmacodynamic effects in subjects with aMCI and elderly controls after one dose of the medication that has been approved for symptomatic treatment in AD.These measures can then be used for the future assessment of potential novel treatments for AD.;Secondary Objective: None;Primary end point(s): Changes in P3a ERP amplitude and latency Changes in P3b ERP amplitude and latency Changes in frequency and power Changes in alpha blocking/desynchronisation Increases in slow wave power (delta and theta) related to downward shifts in arousal or increases in theta/beta ratio The EEG will guide the fMRI analysis. With the incorporation of fMRI the precise anatomical regions where the drugs are impacting on neural activity can be elucidated. | — |
Countries
Ireland
Outcome results
None listed