Are Healthcare interventions Exacerbating Alzheimer's Disease? (AHEAD study)

Not Applicable

Recruiting

• Conditions: Alzheimer's Disease; Dementia; Mild Cogntive Impairment (MCI); Neurological - Dementias; Surgery - Other surgery; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12614000012673
• Lead Sponsor: St Vincent's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-06
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

1. Patients aged >=60 years
2. Mild Cognitive Impairement (MCI) or very-mild to mild dementia (CDR global 0.5 - 1.0)
3. Able to provide written informed consent
4. Live within a reasonable distance of St Vincent's Hospital (for home neuropsychological assessments)
5. No contraindication to neuropsychological testing (eg. language, significant depression, deaf or blind)

Exclusion Criteria

1. Pre-existing neurological or clinically evident neurovascular disease (eg. stroke)
2. Severe dementia (CDR>=2)
3. Dementia known to be due to causes other than AD.
4. Non-english speaker; deafness, blindness
5. Medical co-morbidity that may lead to complications and loss to follow-up

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive decline, as measured by neuropsychological tests including:<br><br>- Mini Mental State Examination (MMSE)<br>- Alzheimer's Disease Assessment Scale (ADAS-Cog)<br>- Controlled Oral Word Assocation Test (COWAT)<br>- Trail Making Test A and B<br>- Semantic word fluency<br>- Digit Symbol Substitution Test (DSST)<br>- Grooved Pegboard (dominant & non dominant hands)[Baseline, 7 days, 3, 12 and 24 months following surgery or enrolment in study (for controls).];functional decline as measured by questionnaires including:<br><br>- Clinical Dementia Rating (CDR)<br>- Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)<br>- AD Cooperative Study (ADCS) Activities of Daily Living Inventory<br>- Quality of Life Short Form 12<br>- ADCS - Clinician's Global Impression of Change[Baseline, 7 days, 3, 12 and 24 months following surgery or enrolment in study (for controls).]

Secondary Outcome Measures

Name	Time	Method
Identify whether patient risk factors, including cardiovascular, Apo-E genotype, postoperative delirium and Post Operative Cognitive Dysfunction (POCD) are associated with longer term deterioration.<br>Postoperative delirium will be measured using the Confusion Assessment Method (CAM) and POCD will be classified using the Reliable Change Index (RCI).[Baseline, day 3 and 7, 3, 12 and 24 months postoperatively]