Differential Effects of donepezil and placebo in mild cognitive impairment and elderly controls.
- Conditions
- Amnestic Mild Cognitive Impairment (aMCI)MedDRA version: 9.1Level: LLTClassification code 10009846Term: Cognitive impairment
- Registration Number
- EUCTR2007-006487-30-IE
- Lead Sponsor
- St. James's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:
Older Controls
• aged between 65-80 years
• absence of symptoms of cognitive impairment
• MMSE score of 27 or higher
• test scores on the neuropsychological battery (see below) that are not more than 1 SD below age-adjusted norms
aMCI Subjects
• aged between 65-80 years,
• symptoms of cognitive impairment for at least 6 months,
• the diagnosis of ‘not demented’ (i.e. CDR status of 0 or 0.5).
• must score greater than 1.5 SD below aged norms on at least one of the following: WMS-III logical memory, visual reproduction or face recognition
• only include as aMCI delayed measures and not immediate measures.
• meet consensus criteria for amnestic MCI (a-MCI; Winblad et al, 2004)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
• Active medical disease or psychiatric illness
• History of head injury, stroke, epilepsy/seizure disorder, heart attack, syncopal or pre-syncopal episode, episodes of unexplained loss of consciousness
• Clinically significant abnormalities on screening ECG, including but not limited to conduction abnormalities or heart rate <55 beats / min as judged by the investigator
• Clinically significant abnormalities on screening laboratory tests as judged by the investigator
• History of major psychiatric illness
• Currently taking psychotropic medication, antidepressants, benzodiazepines or oral steroids.
• History or presence of alcohol/drug abuse/dependency
• Scoring above cut-offs on screening anxiety and depression scales (the Hospital Anxiety and Depression Scale (HADS) depression score >8, anxiety score >8 .
• If English is not their first language
• Any contraindications to taking donepezil as specified in the Summary of Product Characteristics, including history or presence of asthma, chronic obstructive airways disease, peptic ulcers and seizures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method