Mild Cognitive ImpairmentNCT01532739
Making Memory Better for Seniors With Mild Cognitive Impairment
A study testing Cognitive training in people with Mild Cognitive Impairment, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the feasibility and effectiveness of a cognitive training group in individuals with Mild Cognitive Impairment, using a new paradigm that will optimize ecological validity by (1) focusing on everyday memory problems, (2) supplementing traditional memory training with the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 5 Dec 2011to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Mild Cognitive Impairment
Who cannot join
- Clinical diagnosis of dementia
- History of neurological conditions known to impair cognition
- History of alcohol or drug abuse
- History of chronic psychiatric illness
- Current symptoms of moderate to severe depression (Geriatric Depression Scale >19) or anxiety (Beck Anxiety Inventory >15)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Neuropsychology Service, Nova Scotia Hospital
Dartmouth, Nova Scotia, B2Y 3Z9
About this study
Official title: Neuropsychological Intervention for a Seniors Mental Health Population With Mild Cognitive Impairment
The purpose of this study is to investigate the feasibility and effectiveness of a cognitive training group in individuals with Mild Cognitive Impairment, using a new paradigm that will optimize ecological validity by (1) focusing on everyday memory problems, (2) supplementing traditional memory training with the teaching of an empirically-supported problem-solving approach, and (3) employing a clinically representative sample of individuals with MCI (e.g., not excluding those with mild affective symptoms).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Cognitive training
- Keywords
- Mild Cognitive Impairment, Aging, Memory, Executive Function, Cognitive Intervention, Memory Training, Mental Health
- Medical subject headings
- Cognitive Dysfunction, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
The cognitive training consists of 10 weekly 2-hour sessions. It is run with groups of MCI participants and their study partners (who help with reinforcing the strategies in everyday activities). The program provides information about memory and lifestyle factors in the first two weeks, followed by training and practice over the next eight weeks on empirically-supported cognitive strategies known to be effective at supporting day-to-day remembering in MCI. Participants learn to apply a core set of strategies (spaced retrieval, memory book logging) across a variety of common memory problems (e.g., remembering names, appointments, etc). To enhance the likelihood that these strategies will transfer to other settings beyond training, participants are also taught a memory problem solving approach that will cue them to recognize situations in which they need to: (1) stop and remember something, (2) select and apply an appropriate memory strategy, and (3) monitor that it is working.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training | Experimental | Not described Receives: Behavioral: Cognitive training |
| No cognitive training | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in everyday memory functioning
Rivermead Behavioural Memory Test (3rd Edition)
Measured: Measured at baseline and months 3, 5, 8
Secondary outcomes (8)
Change on traditional memory testing
California Verbal Learning Test (2nd Edition)
Measured: Measured at baseline and months 3, 5, 8
Change in memory perception
Multifactorial Metamemory Questionnaire
Measured: Measured at baseline and months 3, 5, 8
Change in mood (i.e., self-report symptoms of depression)
Geriatric Depression Scale
Measured: Measured at baseline and months 3, 5, 8
Change in mood (i.e., self-report symptoms of anxiety)
Beck Anxiety Inventory
Measured: Measured at baseline and months 3, 5, 8
Change in other psychiatric symptoms (informant-report)
Neuropsychiatric Inventory
Measured: Measured at baseline and months 3, 5, 8
Change in quality of life
Zarit Burden Interview
Measured: Measured at baseline and months 3, 5, 8
Change in caregiver burden
Zarit Burden Interview
Measured: Measured at baseline and months 3, 5, 8
Feasibility
Recruitment, retention, and compliance rates
Measured: Measured at end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study start5 Dec 2011
- Primary completion5 Dec 2025 (estimated)
- Study completion5 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Research Foundation
- Responsible party
- Sponsor
- Investigators
- Karen A Chipman, PhD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532739
- Sponsor's protocol ID
- CDHA-RS/2012-227
- Status last verified
- Aug 2024
- First submitted
- 10 Feb 2012
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Intervention for a Seniors Mental Health Population With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01532739
- Acronym / sponsor ID
- CDHA-RS/2012-227
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Aging, Memory, Executive Function, Cognitive Intervention, Memory Training, Mental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Nova Scotia Health Research Foundation
- Study start
- 5 Dec 2011 (actual)
- Primary completion
- 5 Dec 2025 (estimated)
- Study completion
- 5 Dec 2025 (estimated)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the feasibility and effectiveness of a cognitive training group in individuals with Mild Cognitive Impairment, using a new paradigm that will optimize ecological validity by (1) focusing on everyday memory problems, (2) supplementing traditional memory training with the teaching of an empirically-supported problem-solving approach, and (3) employing a clinically representative sample of individuals with MCI (e.g., not excluding those with mild affective symptoms).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive training | Experimental | Behavioral: Cognitive training |
| No cognitive training | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Mild Cognitive Impairment
Key exclusion criteria (5 listed)
- Clinical diagnosis of dementia
- History of neurological conditions known to impair cognition
- History of alcohol or drug abuse
- History of chronic psychiatric illness
- Current symptoms of moderate to severe depression (Geriatric Depression Scale >19) or anxiety (Beck Anxiety Inventory >15)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingThe cognitive training consists of 10 weekly 2-hour sessions. It is run with groups of MCI participants and their study partners (who help with reinforcing the strategies in everyday activities). The program provides information about memory and lifestyle factors in the first two weeks, followed by training and practice over the next eight weeks on empirically-supported cognitive strategies known to be effective at supporting day-to-day remembering in MCI. Participants learn to apply a core set of strategies (spaced retrieval, memory book logging) across a variety of common memory problems (e.g., remembering names, appointments, etc). To enhance the likelihood that these strategies will transfer to other settings beyond training, participants are also taught a memory problem solving approach that will cue them to recognize situations in which they need to: (1) stop and remember something, (2) select and apply an appropriate memory strategy, and (3) monitor that it is working. | Behavioural | Cognitive training |
Primary outcome
Change in everyday memory functioning
Time frame: Measured at baseline and months 3, 5, 8
Rivermead Behavioural Memory Test (3rd Edition)
8 secondary outcomes
Change on traditional memory testing
Time frame: Measured at baseline and months 3, 5, 8
Change in memory perception
Time frame: Measured at baseline and months 3, 5, 8
Change in mood (i.e., self-report symptoms of depression)
Time frame: Measured at baseline and months 3, 5, 8
Change in mood (i.e., self-report symptoms of anxiety)
Time frame: Measured at baseline and months 3, 5, 8
Change in other psychiatric symptoms (informant-report)
Time frame: Measured at baseline and months 3, 5, 8
Change in quality of life
Time frame: Measured at baseline and months 3, 5, 8
Change in caregiver burden
Time frame: Measured at baseline and months 3, 5, 8
Feasibility
Time frame: Measured at end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
Related trials for Mild Cognitive Impairment
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen A Chipman, PhD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training in people with Mild Cognitive Impairment, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in everyday memory functioning (time frame: Measured at baseline and months 3, 5, 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.