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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03278743
Other study ID # UNewcastle
Secondary ID
Status Completed
Phase N/A
First received August 14, 2017
Last updated September 8, 2017
Start date June 2006
Est. completion date March 2013

Study information

Verified date September 2017
Source Newcastle University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Studies have found a beneficial effect of tea consumption on the reduction of risk of cognitive impairment and dementia in older aged populations. However, there is a paucity of data on these associations in the very old defined as individuals aged 85 years and over. Therefore, we hypothesized that higher tea consumption was associated with better global and domain-specific cognitive function. We investigated the relationship between tea consumption in the very old and measures of global cognitive function, memory, attention and psychomotor speed.

The Newcastle 85+ Study was a longitudinal (5-years), population-based cohort study of individuals aged 85+ years in North East England, United Kingdom. The final sample included 676 community-dwelling and institutionalized men and women recruited through general medical practices.

Baseline tea consumption was assessed through a 2x24-hr multiple pass recall and longitudinal measures of global and domain specific (memory, speed and attention) cognitive function through the standardized mini-mental state examination and the cognitive drug research system. Linear mixed models, controlling for demographic (e.g. age, sex and education) and health variables were used to determine whether tea consumption was protective against cognitive decline.


Recruitment information / eligibility

Status Completed
Enrollment 1042
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 85 Years to 85 Years
Eligibility Inclusion Criteria:

- Born in 1921

- Permanently registered with a participating general practice in Newcastle upon Tyne or North Tyneside primary care trusts in the UK

Exclusion Criteria:

- End-stage illness

- Individuals who might pose a safety risk to a nurse visiting alone, with dementia

- Clinical diagnosis of dementia at baseline

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cognitive performance and cognitive decline
Assess the global and domain specific (memory, speed and attention) cognitive function at baseline and over 5 years in the high vs. low/moderate tea consumption groups

Locations

Country Name City State
United Kingdom Newcastle University Newcastle upon Tyne

Sponsors (1)

Lead Sponsor Collaborator
Newcastle University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Standardized mini-mental state examination Measure of global cognition (Score 0-30) Baseline
Primary Rate of decline of the standardized mini-mental state examination Measure of global cognition (Score 0-30) Baseline to 5 years follow-up
Secondary Simple reaction time Simple reaction time assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. The participant is instructed to press "YES" as quickly as possible every time the word "YES" is presented on the screen. In total, 30 "YES" stimuli are presented with varying inter-stimulus interval. (ms) Baseline
Secondary Rate of reaction speed decline Simple reaction time assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box.The participant is instructed to press "YES" as quickly as possible every time the word "YES" is presented on the screen. In total, 30 "YES" stimuli are presented with varying inter-stimulus interval. (ms) Baseline to 3 years follow-up
Secondary Choice reaction time Choice reaction time assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. Either the word "YES" or "NO" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 30 trials for each stimulus word, which is chosen randomly with equal probability, with varying inter-stimulus interval. (ms) Baseline
Secondary Rate of reaction choice decline Choice reaction time assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box.Either the word "YES" or "NO" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 30 trials for each stimulus word, which is chosen randomly with equal probability, with varying inter-stimulus interval. (ms) Baseline to 3 years follow-up
Secondary Digit vigilance task Digit vigilance task assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. Target digit is randomly selected and constantly displayed to the right of the screen. A series of digits (0-9) are presented in the centre of the screen at the rate of 150 per minute. The participant is required to press the "YES" button as quickly as possible every time the digit in the series matches the target digit. There are 300 digits in the series and the task lasts for 2 minutes. (ms) Baseline
Secondary Rate of digit vigilance task decline Digit vigilance task assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. Target digit is randomly selected and constantly displayed to the right of the screen. A series of digits (0-9) are presented in the centre of the screen at the rate of 150 per minute. The participant is required to press the "YES" button as quickly as possible every time the digit in the series matches the target digit. There are 300 digits in the series and the task lasts for 2 minutes. (ms) Baseline to 3 years follow-up
Secondary Word recognition Word recognition was assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box. A list of words is presented on screen for the subject to remember. Immediately after the presentation the subject is asked to recall as many words as possible. 20 minutes later, the same list of words is presented with added distracter words. For each word, the subject is asked to indicate whether or not it belongs o the original list by pressing 'YES' or 'NO'. Baseline
Secondary Rate of word recognition decline Word recognition was assessed using the Cognitive Drug Research (CDR) computerised system. The CDR tasks were presented on a hi-resolution Windows-based laptop computer (Motion Computing LE1600 Tablet PC with keyboard accessory) and participants responded using a two-button (NO/YES) response box.A list of words is presented on screen for the subject to remember. Immediately after the presentation the subject is asked to recall as many words as possible. 20 minutes later, the same list of words is presented with added distracter words. For each word, the subject is asked to indicate whether or not it belongs to the original list by pressing 'YES' or 'NO'. Baseline to 3 years follow-up
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