Brain enhancement study (BES): A multi-modal lifestyle-based intervention for individuals with amnestic mild cognitive impairment
- Conditions
- Mild Cognitive impairmentNeurological - Other neurological disorders
- Registration Number
- ACTRN12624000281594
- Lead Sponsor
- Vitality Works
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 51
a.Meets the National Institute on Aging-Alzheimer’s Association workgroups diagnostic guidelines for MCI due to Alzheimer’s disease (Albert 2011), as indicated by:
i.A score of 1.0-1.5 standard deviations below the age standardised mean for at least two memory associated measures plus one other measure which may or may not be memory related, as
ii.Independence in functional activities as indicated by a score greater than 51 on the Amsterdam Instrumental Activities of Daily Living (A-IADL-Q;,
iii.Change in cognition as reported by the participants study companion; indicated by a score equal to 3.19 on the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) OR a change in cognition as reported by a physician,
b.Aged between 65 years and 85 years,
c.Willing and able to undertake significant behavioural change in line with the intervention guidelines
d.Willing and able to adhere to personal recommendations, made within the Intervention Guidelines to facilitate meeting of Biochemical and Physiological Targets
e.Able to participate in the entire study (24 weeks) with a study companion that knows the participant well and has daily contact with the participant,
f.Able to participate in the 5 ½ day Intensive workshop (Intervention: Phase 2) with their study companion.
a.Known medical conditions:
i.Unstable angina,
ii.Postural hypotension (i.e. greater than 20 mmHg),
iii.Uncontrolled atrial or ventricular arrhythmias,
iv.Unstable heart failure,
v.Significant aortic stenosis,
vi.Unrecovered neurological disorder (e.g., stroke, traumatic brain injury etc.),
vii.Currently suffering from an acute inflammatory bowel condition (e.g., severe IBS, ulcerative colitis, Crohn’s disease or any other gastrointestinal condition likely to impede food absorption)
b.Currently prescribed Warfarin,
c.Prescribed medication known to significantly affect cognition (e.g., sedatives/hypnotics, narcotics, anticholinergics, 1st generation antihistamines),
d.Currently receiving chemo or radiotherapy for cancer,
e.Have received chemotherapy within the last 24 months,
f.Have undergone surgery with general anaesthesia within the last 6 months,
g.Indication of tobacco, alcohol, or other substance use disorder,
h.Concurrent participation in another study or health program,
i.Known allergy/intolerance to omega-3 supplements or the use of prescribed medications known to adversely interact with omega-3 supplements,
j.Known allergy/intolerance to ingredients within Memorease (refer to Investigational Brochure) or the use of prescribed medications known to adversely interact with ingredients within Memorease,
k.Likelihood of a current major depressive episode (as indicated by a score greater than 18 on the Cornell Scale for Depression in Dementia, CSDD or other psychological disorder (e.g., schizophrenia, obsessive compulsive disorder, Down syndrome),
l.Poorly controlled diabetes as indicated by a fasting blood glucose concentration equal to or greater than 7.0 mmol/L and/or HbA1c equal to or greater than 6.5% (48 mmol/mol),
m.Poorly controlled hyper/hypothyroidism as indicated by abnormal thyroid function test results,
n.Resting tachycardia greater than 100 bpm,
o.Systolic blood pressure equal to or greater than 180 and/or diastolic equal to or greater than 100 mmHg,
p.Uncontrolled sleep apnoea as indicated by categorisation as ‘high risk’ for sleep apnoea on the Berlin questionnaire).
q.Significant physical limitations or illness preventing compliance with study guidelines.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Any change in the composite assessment of neurocognitive functions and processes including psychomotor and motor speed, reasoning and planning abilities, memory and attention, and frontal, temporal and hippocampal dysfunctions.[Cambridge Neuropsychological Test Automated Battery (CANTAB), Assessment at baseline, 12 and 24 weeks (primary end point) post intervention commencement];Any change in the composite assessment of attention, orientation, memory, language, visual perceptual and visuospatial skills[Addenbrooke's Cognitive Examination III (ACE III) Assessment at baseline, 12 and 24 weeks (primary end point) post intervention commencement]
- Secondary Outcome Measures
Name Time Method