Amnestic Mild Cognitive Impairment (aMCI) MedDRA version: 9.1 Level: LLT Classification code 10009846 Term: Cognitive impairment
Conditions
Interventions
Trade Name: Aricept® 5 mg 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
Sponsors
St. James's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to define the short-term effects of the existing Alzheimer's Disease (AD) symptomatic treatment compound donepezil on cognitive EEG/ERP endpoints and olfactory discrimination in normal elderly and amnestic mild cognitive impairment (aMCI) cohorts. The overall goal of the study is to develop EEG/ERP measures that can detect pharmacodynamic effects in subjects with aMCI and elderly controls, after short-term treatment with medications that have 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: ;Primary end point(s): The following endpoints are examples of a few of a large number of potential endpoints from a large quantity of EEG data: 1. Resting EEG Extraction of background spectral power (delta, theta, alpha, beta) Reduced alpha blocking/desynchonisation (eyes open vs eyes closed) Eyes open/eyes closed – damping ratio (magnitude of change in synchronization) 2. SARTfixed Increased amplitude in P1 and NI components on trial 2 N300 seen as phasic negativity over the occipitoparietal scalp between 300 &500ms on trial 2. A later prospective positivity broadly distributed (500-1000ms) over parietal areas. Late Positive 1 (LP1) will be observed 550-800ms following trial 2 onset and will exhibit divergence between correct and incorrect target (3) responding. 3. Learn/No Learn Task (ERP components of relevance) Cue information: Increased sensory facilitation of cue information (early ERP components P1, N1) Increased anticipatory potentials linked to biasing brain attentional set (parietal, midline frontal and lateral frontal). Word encoding: Increased sensory processing of learn word information relative to no-learn word & letter strings. Components linked to word/non-word processing (latency & amplitude) Increased N2/P3 amplitude Word recognition: Recognition memory studies have suggested that event-rela | — |
Countries
Ireland
Outcome results
None listed