The differential effects of donepezil and placebo on EEG/ ERP measures and fMRI in mild cognitive impairment and elderly controls - donepezil and placebo on EEG/ ERP measures and fMRI

• Conditions: Amnestic Mild cognitive Impairment (aMCI); MedDRA version: 9.1Level: LLTClassification code 10009846Term: Cognitive impairment

• Registration Number: EUCTR2009-011582-88-IE
• Lead Sponsor: St James Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-15
• Last Update Posted: 26 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified