Mild Cognitive ImpairmentPhase 1NCT00609427
Effects of Cognitive Intervention for Older Adults With Memory Decline: A Pilot Study
A Phase 1 study testing MEMO programme (Inst Universitaire de Geriatrie, Montreal) and External memory aids training in people with Mild Cognitive Impairment, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effects of training in memory skills vs. use of external memory aids on everyday memory functioning in older people with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- MEMO programme (Inst Universitaire de Geriatrie, Montreal) and External memory aids training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to May 2010
- Phase
- Phase 1
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Clinical diagnosis of mild cognitive impairment
Who cannot join
- Unable to speak and understand English
- Unable to comply with treatment program due to significant comorbid illness; OR
- Anticipated inability to attend all study sessions
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effects of training in memory skills vs. use of external memory aids on everyday memory functioning in older people with mild cognitive impairment.
Read the detailed description
Some older people experience memory loss that is worse than other people of their age, although they are not demented. This condition is known as mild cognitive impairment (MCI). Healthy older people can learn mnemonic strategies to improve their memory abilities. Can cognitive rehabilitation help people with MCI do better on mental tasks or maintain better functioning in everyday life? This study will evaluate the effects of two different rehabilitation programmes. Patients in the memory training group will learn mental strategies aimed at improving memory. Patients in the memory compensation group will learn to use external memory aids.
- Conditions
- Mild Cognitive Impairment
- Being tested
- MEMO programme (Inst Universitaire de Geriatrie, Montreal), External memory aids training
- Keywords
- cognitive training, cognitive rehabilitation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMO programme (Inst Universitaire de Geriatrie, Montreal)Behavioural
8 weekly group training sessions in mnemonic strategies, administered by clinical psychologist.
External memory aids trainingBehavioural
8 weekly group sessions of training in the use of external memory aids, administered by clinical psychologist
| Study group | Role | What they receive |
|---|---|---|
| EA | Experimental | Training in external memory aids Receives: Behavioral: External memory aids training |
| MT | Experimental | Mnemonic training intervention Receives: Behavioral: MEMO programme (Inst Universitaire de Geriatrie, Montreal) |
| WL | No intervention | Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rey Auditory Verbal Learning Test
Measured: 19-20 weeks
Wechsler Memory Scale - Logical Memory
Measured: 19-20 weeks
Face-name associations test
Measured: 19-20 weeks
Multifactorial Memory Questionnaire - Ability subscale
Measured: 19-20 weeks
Secondary outcomes (6)
Rivermead Behavioural Memory Test
Measured: 19-20 weeks
FAS test (non-memory)
Measured: 19-20 weeks
Category fluency (non-memory test)
Measured: 19-20 weeks
Victoria Stroop Test (non-memory test)
Measured: 19-20 weeks
Digit Span (non-memory test)
Measured: 19-20 weeks
Multifactorial Memory Questionnaire - Strategies and Contentment subscales
Measured: 19-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2010
- Study completionMay 2010
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.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Lisa Koski, PhD, Principal investigator, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609427
- Sponsor's protocol ID
- PSY-07-015
- Status last verified
- Jun 2010
- First submitted
- 24 Jan 2008
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Intervention for Older Adults With Memory Decline: A Pilot Study
- ClinicalTrials.gov ID
- NCT00609427
- Acronym / sponsor ID
- PSY-07-015
- Conditions
- Mild Cognitive Impairment
- Keywords
- cognitive training, cognitive rehabilitation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Feb 2008 (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 evaluate the effects of training in memory skills vs. use of external memory aids on everyday memory functioning in older people with mild cognitive impairment.
Detailed description
Some older people experience memory loss that is worse than other people of their age, although they are not demented. This condition is known as mild cognitive impairment (MCI). Healthy older people can learn mnemonic strategies to improve their memory abilities. Can cognitive rehabilitation help people with MCI do better on mental tasks or maintain better functioning in everyday life? This study will evaluate the effects of two different rehabilitation programmes. Patients in the memory training group will learn mental strategies aimed at improving memory. Patients in the memory compensation group will learn to use external memory aids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EA | Experimental | Behavioral: External memory aids trainingTraining in external memory aids |
| MT | Experimental | Behavioral: MEMO programme (Inst Universitaire de Geriatrie, Montreal)Mnemonic training intervention |
| WL | No intervention | –Wait-list control |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of mild cognitive impairment
Key exclusion criteria (3 listed)
- Unable to speak and understand English
- Unable to comply with treatment program due to significant comorbid illness; OR
- Anticipated inability to attend all study sessions
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 |
|---|---|---|
| MEMO programme (Inst Universitaire de Geriatrie, Montreal)8 weekly group training sessions in mnemonic strategies, administered by clinical psychologist. | Behavioural | MT |
| External memory aids training8 weekly group sessions of training in the use of external memory aids, administered by clinical psychologist | Behavioural | EA |
Primary outcome
Rey Auditory Verbal Learning Test
Time frame: 19-20 weeks
Wechsler Memory Scale - Logical Memory
Time frame: 19-20 weeks
Face-name associations test
Time frame: 19-20 weeks
Multifactorial Memory Questionnaire - Ability subscale
Time frame: 19-20 weeks
6 secondary outcomes
Rivermead Behavioural Memory Test
Time frame: 19-20 weeks
FAS test (non-memory)
Time frame: 19-20 weeks
Category fluency (non-memory test)
Time frame: 19-20 weeks
Victoria Stroop Test (non-memory test)
Time frame: 19-20 weeks
Digit Span (non-memory test)
Time frame: 19-20 weeks
Multifactorial Memory Questionnaire - Strategies and Contentment subscales
Time frame: 19-20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
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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.
Lisa Koski, PhD principal investigator
Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEMO programme (Inst Universitaire de Geriatrie, Montreal) and External memory aids training in people with Mild Cognitive Impairment, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 3 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: finished, as of the sponsor's last update on 2 Jun 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rey Auditory Verbal Learning Test (time frame: 19-20 weeks). The study lists 4 primary outcomes in all. 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 2 Jun 2010.