The AUstralian multidomain Approach to Reduce dementia Risk by prOtecting brain health With lifestyle intervention study (AU-ARROW)

Not Applicable

Recruiting

• Conditions: Alzheimer's disease; Dementia; Neurological - Alzheimer's disease; Neurological - Dementias

• Registration Number: ACTRN12621001760864
• Lead Sponsor: Macquarie University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-23
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

•Age 55 – 79 years
•Sedentary lifestyle
•Lives independently
•Not allergic to seafood
•Must have internet access, mobile phone, and computer or iPad at home
•Lives in a region where the interventions will be delivered
•Participants must be willing to complete all study-related activities for the 24 months of the trial
•Participants must be able to provide written consent in English.
•Participants must not have any physical disabilities that would preclude them being able to complete any of the lifestyle intervention domains.
•Does not plan to travel outside of the home geographic area (to the extent that attending group meetings, assessment visits, or gym sessions (if in the ML group) are not feasible), for more than 1 month at a time, or for more than 3 months over the course of the study
•Poor diet
•Current absence of significant cognitive impairment according to Clinical Dementia Rating (CDR) scale (less than or equal to 0.5), or CDR-sum of boxes (less than or equal to 1), also passing a validated telephone administered cognitive battery (telephone MoCA score greater than or equal to 18)
•Needs to satisfy at least 1/4 of the following 4 criteria:
1- Increased vascular and /or metabolic risk factors, as indicated by systolic blood pressure greater than or equal to 125 mm Hg at screening, or on treatment for hypertension, LDL cholesterol at greater than or equal to 3.0 mmol/L at screening, TG/HDL ratio greater than 1.0 at screening, or on treatment for dyslipidaemia, or glycated haemoglobin at 6% (42 mmol/L) or higher at screening, or on treatment for diabetes (except insulin)
2- Aged 70 or over
3- First or second degree family history of significant cognitive decline/memory problems/dementia (including parents, siblings, aunts/uncles, grandparents and/or half-siblings)
4- Body Mass Index (BMI) 30-39.9

Exclusion Criteria

•Body Mass Index (BMI) greater than or equal to 40
•Regular use of prescribed or over the counter medication with cognitive adverse effects, including opiates/opioids, anticholinergics, antiepileptics, or benzodiazepines; also use of mood-stabilising psychotropics, psychostimulants, or antipsychotics within the last 3 months
•On anti-depressants, unless on stable dose for 4 weeks prior to screening
•Regular use of systemic corticosteroids
•Any significant neurologic disease, including any form of dementia, mild cognitive impairment, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumour, progressive supranuclear palsy, seizure disorder, subdural haematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities
•Current or past use of medications for memory impairment or AD (e.g., cholinesterase inhibitors, memantine)
•Any history of bipolar disorder or schizophrenia as per DSM V (Diagnostic and statistical manual of Mental Disorders V) criteria
•History of major depression in last 6 months
•History of alcohol or substance abuse or dependence within the past 2 years, as per DSM V criteria, or pattern of alcohol use over the last 3 months averaging in excess of 21 standard drinks per week or 4 standard drinks in any given day
•Significant cardiovascular disease (including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, or uncontrolled angina)
•Serious conduction disorder (e.g. 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm) on ECG (treated atrial fibrillation for more than 1 year or occasional premature ventricular contractions on ECG are not exclusions)
•Myocardial infarction, major heart surgery (i.e. valve replacement, bypass surgery, stent placement, angioplasty), deep vein thrombosis, or pulmonary embolus in the past 6 months
•Large vessel stroke in the past 2 years
•History of Transient Ischaemic Attack (TIA) or small vessel stroke in the last 6 months; TIA occurring more than 6 months ago with residual effects
•Lung disease requiring oral corticosteroids or oxygen
•Clinically significant abnormalities in laboratory blood test results as per site study clinician
•Renal disease (eGFR needs to be over 30 mL/min)
•Past or current use of insulin to treat type 2 diabetes
•Current or past history of gall bladder stones (cholecystectomy accepted)
•History within the last 2 years of treatment for primary or recurrent malignant disease, excluding non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
•History of hip fracture, joint replacement, or spinal surgery within last 6 months
•Currently receiving physical therapy or cardiopulmonary rehabilitation
•Currently receiving dietitian advice
•History of a malabsorptive bariatric procedure (gastric bypass, biliopancreatic diversion); or other bariatric procedures involving restriction (i.e., sleeve, band)
•Site PI/Study Clinician discretion regarding medical status, appropriateness of participation or concern about intervention adherence
•Enrolment in another clinical trial, either currently, or in the 30 days prior to randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Primary Outcome is a Global Cognitive composite Score.<br>The global composite score will include scores from the Free and Cued Selective Reminding Test, Immediate and Delayed Visual Paired Associates, Number Span forward, backward and sequencing, Verbal Fluency by letters (F,A,S) and by Category (animals, vegetables, fruits), Digit Symbol Substitution Test, Immediate and Delayed Story Recall, and Trail making tests A and B. [ 24 months after start of intervention, compared to baseline measurement (0 months).]