Mild Cognitive ImpairmentMST trainingNCT04533204
Mnemonic Strategy Versus Spaced Retrieval Training in Those With Mild Cognitive Impairment
A study testing mnemonic strategy training and spaced retrieval training in people with Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study compared two active cognitive interventions to evaluate whether one improved memory more than the other in patients with mild cognitive impairment. Participants were randomized to either memory strategy training or spaced retrieval training and completed memory tests before and after 3 training sessions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- mnemonic strategy training and spaced retrieval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2010to 30 Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- -Diagnosis of MCI according to Petersen (2004) criteria, right handed
Who cannot join
- Diagnosis of other neurological condition,
- active drug/alcohol abuse/dependence,
- moderate-severe depression or other Axis I diagnoses.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
About this study
Official title: Comparing Mnemonic Strategy With Spaced Retrieval Training in Patients With Mild Cognitive Impairment (B6366-W)
This study compared two active cognitive interventions to evaluate whether one improved memory more than the other in patients with mild cognitive impairment. Participants were randomized to either memory strategy training or spaced retrieval training and completed memory tests before and after 3 training sessions. Participants returned 1 month after treatment to see how well they remembered the learned information. Brain scans (functional MRI) were collected before and after the interventions to see if training changed the way brain regions were functioning.
Read the detailed description
Individuals with MCI were randomized to 3 sessions of mnemonic strategy or spaced retrieval training that focused on object location associations. Across these training sessions, each group received 9 training trials for each of the 45 trained stimuli. Task-fMRI was acquired before and after training. Memory was again evaluated 1 month after the last training session. The primary outcome measure was memory for the "trained" stimuli while secondary outcome was accuracy for novel stimuli acquired outside of the MRI environment.
- Conditions
- Mild Cognitive Impairment
- Being tested
- mnemonic strategy training, spaced retrieval training
- Keywords
- MCI, cognitive training, memory training, dementia, Alzheimer's disease
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mnemonic strategy trainingBehavioural
training using mnemonic strategies
spaced retrieval trainingBehavioural
training using spaced retrieval
| Study group | Role | What they receive |
|---|---|---|
| Mnemonic strategy training | Experimental | Training using mnemonic strategies Receives: Behavioral: mnemonic strategy training |
| Spaced retrieval training | Active comparator | Training using spaced retrieval Receives: Behavioral: spaced retrieval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Correct Object Location Associations Assessed up to 1 Month Post-treatment
Change in memory for 45 trained object location associations
Measured: up to 1 month after last training session
Secondary outcomes (1)
Change in Accuracy (vs. Baseline) on Novel Object Location Associations
Change in accuracy for novel object location associations using a touchscreen task; distance measured in cm from actual location
Measured: up to 1 month after last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Aug 2010
- Primary completion30 Jun 2014
- Study completion30 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to Mnemonic strategy or spaced retrieval training
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Benjamin M. Hampstead, PhD, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533204
- Sponsor's protocol ID
- B6366-W-1
- Acronym
- MST training
- Status last verified
- Nov 2020
- First submitted
- 25 Aug 2020
- Last updated
- 23 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Mnemonic Strategy With Spaced Retrieval Training in Patients With Mild Cognitive Impairment (B6366-W)
- ClinicalTrials.gov ID
- NCT04533204
- Acronym / sponsor ID
- MST training / B6366-W-1
- Conditions
- Mild Cognitive Impairment
- Keywords
- MCI, cognitive training, memory training, dementia, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Jul 2014 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Posted 23 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compared two active cognitive interventions to evaluate whether one improved memory more than the other in patients with mild cognitive impairment. Participants were randomized to either memory strategy training or spaced retrieval training and completed memory tests before and after 3 training sessions. Participants returned 1 month after treatment to see how well they remembered the learned information. Brain scans (functional MRI) were collected before and after the interventions to see if training changed the way brain regions were functioning.
Detailed description
Individuals with MCI were randomized to 3 sessions of mnemonic strategy or spaced retrieval training that focused on object location associations. Across these training sessions, each group received 9 training trials for each of the 45 trained stimuli. Task-fMRI was acquired before and after training. Memory was again evaluated 1 month after the last training session. The primary outcome measure was memory for the "trained" stimuli while secondary outcome was accuracy for novel stimuli acquired outside of the MRI environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomization to Mnemonic strategy or spaced retrieval training
| Arm | Type | Receives |
|---|---|---|
| Mnemonic strategy training | Experimental | Behavioral: mnemonic strategy trainingTraining using mnemonic strategies |
| Spaced retrieval training | Active comparator | Behavioral: spaced retrieval trainingTraining using spaced retrieval |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -Diagnosis of MCI according to Petersen (2004) criteria, right handed
Key exclusion criteria (3 listed)
- Diagnosis of other neurological condition,
- active drug/alcohol abuse/dependence,
- moderate-severe depression or other Axis I diagnoses.
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 |
|---|---|---|
| mnemonic strategy trainingtraining using mnemonic strategies | Behavioural | Mnemonic strategy training |
| spaced retrieval trainingtraining using spaced retrieval | Behavioural | Spaced retrieval training |
Primary outcome
Percent of Correct Object Location Associations Assessed up to 1 Month Post-treatment
Time frame: up to 1 month after last training session
Change in memory for 45 trained object location associations
1 secondary outcome
Change in Accuracy (vs. Baseline) on Novel Object Location Associations
Time frame: up to 1 month after last training session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Benjamin M. Hampstead, PhD principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mnemonic strategy training and spaced retrieval training in people with Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.
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 23 Mar 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Correct Object Location Associations Assessed up to 1 Month Post-treatment (time frame: up to 1 month after last training session). 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 23 Mar 2021.