Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07411105

Cognition in Older Adults With Cancer Receiving Systemic Anti-Cancer Therapy

The majority of cancer diagnoses occur in adults age 65 years and over. This population is also rapidly expanding. There is a growing need for increased understanding about the potential impact of various newer therapies on common geriatric impairments in this group.

The aim of this study is to examine how feasible it is to carry out a study of cognitive function in older adults (age 65+) who are newly commencing anti-cancer treatments, specifically 'immune checkpoint inhibitor' therapy, over time. Participants in the study undergo four tests of memory and concentration every six weeks for a six month period. Additionally, the researcher will gather information about the participants' non-cancer therapy medications, physical and psychological symptoms, day to day functioning and any changes to these factors over time.

The purpose of the study is to examine a) recruitment, retention and engagement of participants to study procedures; b) to gather preliminary information about cognitive function in older adults commencing immune checkpoint inhibitor treatments and potential associations with cognitive decline over time.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Cancer Cognition Neoplasms Older Adults (65 Years and Older)

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. James's Hospital, Dublin, Dublin, Ireland

Loading trial locations.

About this study

Despite cognitive concerns being commonly described by many patients with cancer, the majority of literature focuses on the impact of chemotherapy and more recently, hormone therapies, on cognitive function. Immune checkpoint inhibitors have revolutionised the management of many cancer types, and their indications are continuing to expand. There is insufficient evidence in the literature regarding the impact of therapy on cognitive function, and particularly in older adult age groups, who may be more susceptible to the cognitive effects of treatments.

Research Hypothesis:

A significant proportion of older adults receiving ICIs have cognitive impairment at the time of cancer diagnosis and that cognition deteriorates in this cohort of adults over the course of their illness due to many factors.

Aim:

To evaluate trajectories of cognitive decline in older adults with cancer commencing ICI therapy over time and to examine associated factors which may influence the trajectory of cognitive decline in this population.

Study Design:

Feasibility Prospective Observational Study

Methodology:

Adults age 65+, newly commencing immune checkpoint inhibitor therapy recruited to this study undergo six-weekly assessments for a six month period. Each assessment includes a commonly used screening tool for mild cognitive impairment, examining global cognition - the Montreal Cognitive Assessment (MoCA); supplemented with 3 neuropsychological tests evaluating verbal learning and memory (Hopkins Verbal Learning Test - Revised), executive function (Controlled Oral Word Association Test) and executive function & processing speed (Trail-Making Test part A&B). These supplementary tests have been recommended by the International Cognition in Cancer Task force as minimum neuropsychological tests that should be included to homogenise research in this field.

Additional data is collected per participant regarding: education status, frailty status, performance status, non-cancer therapy prescriptions, physical and psychological symptoms, recent falls and hospitalisations.

The target recruitment sample is 30 patients, as this is a feasibility study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 65 years and over
  • Newly commencing immune checkpoint inhibitor therapy (either monotherapy, dual therapy or in combination with other anti-cancer therapies)

Exclusion criteria

  • Unable to complete/engage in study assessment procedures
  • Unable to provide informed consent
  • Previous ICI therapy

Treatment and study plan

Primary outcomes

  1. Recruitment

    Time frame: From recruitment start date (May 2024) to recruitment end date (December 2025) (18 months)

    25% of those given a Patient Information Leaflet during the recruitment period (18 months i.e. from May 2024 to December 2025) consent to the study procedures and enter the study

  2. Retention

    Time frame: 3 months from individual participant study commencement date

    50% who are still on treatment complete the 3-month assessment (primary endpoint)

  3. Adherence/Engagement

    Time frame: 3 months from individual participant study start date

    75% of cognitive tests are completed up to and including the 3-month timepoint

  4. Adherence/Engagement

    Time frame: 3 months from individual study participant start date

    75% of assessments are completed within 10 days of the 6-weekly timepoint

Other outcomes

  1. Exploratory Primary Endpoint

    Time frame: Following completion of primary endpoint (3 months)

    The primary (exploratory) endpoint will be development or worsening of cognitive impairment at 3 months as defined by MOCA cut-offs for mild, moderate and severe cognitive impairment.

    Age, education and sex-matched participant MOCA results from the Irish Longitudinal Study of Ageing (TILDA) will be used to provide 2 comparator groups in the analysis: a) age and sex-matched participants without cancer and b) age and sex-matched participants with cancer (i.e. an active cancer diagnosis or a diagnosis of cancer within 5 years prior to wave 6)

  2. Exploratory Secondary Endpoints

    Time frame: From baseline assessment (T0) to 6-month assessment (T4) i.e. at each 6-weekly assessment for a 6 month period from the time of baseline assessment.

    Development or worsening of cognitive impairment (based on MOCA score) at all study time points (see above). Cognitive impairment is defined as a MOCA score of <26/30 based on the MoCA validation study. A change in MOCA score of 4 points or more indicates clinically significant change for an individual participant.

  3. Exploratory Secondary Endpoints

    Time frame: At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)

    Correlation between cognition (MOCA score 0-30) and ECOG-PS (score 0-4)

  4. Exploratory Secondary Endpoints

    Time frame: At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)

    Correlation between cognition (MOCA score 0-30) and cancer stage (metastatic vs. non metastatic disease)

  5. Exploratory Secondary Endpoints

    Time frame: At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)

    Correlation between cognition (MOCA score 0-30) and physical symptoms (MSAS-SF physical subscale score)

  6. Exploratory Secondary Endpoints

    Time frame: At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)

    Correlation between cognition (MOCA score 0-30) and psychological symptoms (MSAS-SF psychological subscale score)

  7. Exploratory Secondary Endpoints

    Time frame: At primary endpoint (i.e. 3 months from time of study entry for each individual participant) (T2)

    Correlation between polypharmacy (5 or more medications) and cognition (MOCA score 0-30)

Sponsors and collaborators

Lead sponsor

Our Lady's Hospice and Care Services

Other

Collaborators

  • St Vincent's University Hospital, Ireland
  • St. James's Hospital, Ireland
  • University of Dublin, Trinity College

Registry information

Official study title

Evaluating Cognitive Trajectories in Older Adults With Cancer

Acronym: CORreCT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.