Mild Cognitive Impairment (MCI)Phase 2NCT01212692
Effects of Mental Stimulation in Patients With Mild Cognitive Impairment
A Phase 2 study testing mentally stimulating activities in people with Mild Cognitive Impairment (MCI), run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to learn if activities that challenge the brain (mentally stimulating activities) can improve memory and other types of thinking in patients with Mild Cognitive Impairment. The study will compare the effects of different methods of mental stimulation. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- mentally stimulating activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2014
- Phase
- Phase 2
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 50 years of age
- meet criteria for amnestic-Mild Cognitive Impairment (MCI)
- have capacity to give informed consent
- have capacity to complete assessment measures
Who cannot join
- history of drug or alcohol dependence
- severe psychiatric conditions associated with psychosis (e.g., schizophrenia)
- recent stroke
- clinical diagnosis of probable Alzheimer's Disease
- history of seizure disorder, serious head trauma, or other medical, psychiatric, or neurological conditions associated with significant cognitive impairment (e.g., Parkinson's Disease, Korsakoff's, HIV)
- current use of Alzheimer's Disease medications (e.g., cholinesterase inhibitors, memantine)
Trial locations and contacts
1 site in 1 country.
United States1 site
BPRU, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: A Theoretically Based Memory Training Intervention in Mild Cognitive Impairment
The purpose of this study is to learn if activities that challenge the brain (mentally stimulating activities) can improve memory and other types of thinking in patients with Mild Cognitive Impairment. The study will compare the effects of different methods of mental stimulation.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- mentally stimulating activities
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mentally stimulating activitiesBehavioural
The study will compare the effects of different methods of mental stimulation. The intervention involves 6 classroom-style educational sessions and 10 mental stimulation studies involving computerized memory tasks.
| Study group | Role | What they receive |
|---|---|---|
| Mentally stimulating activities | Experimental | Not described Receives: Behavioral: mentally stimulating activities |
| Mentally stimulating activities- other | Active comparator | Not described Receives: Behavioral: mentally stimulating activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Ordered Pointing Task
Measured: baseline
Trail-Making
Measured: baseline
Timed Instrumental Activities of Daily Living
Measured: baseline
Rey Auditory Verbal Learning Test
Measured: baseline
Self-ordered pointing task
Measured: immediately after the intervention
Self-ordered pointing task
Measured: 3 months post intervention
Self-ordered pointing task
Measured: 9 months post-intervention
Trail-Making
Measured: immediately after the intervention
Trail-Making
Measured: 3 months post-intervention
Trail-Making
Measured: 9 months post-intervention
Timed Instrumental Activities of Daily Living
Measured: immediately after the intervention
Timed Instrumental Activities of Daily Living
Measured: 3 months post-intervention
Timed Instrumental Activities of Daily Living
Measured: 9 months post-intervention
Rey Auditory Verbal Learning Test
Measured: immediately after the intevention
Rey Auditory Verbal Learning Test
Measured: 3 months post-intervention
Rey Auditory Verbal Learning Test
Measured: 9 months post-intervention
Secondary outcomes (12)
Clinical Dementia Rating Scale
Measured: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Digit Symbol Substitution Test
Measured: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Digit Span
Measured: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Verbal Fluency Test
Measured: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Geriatric Depression Scale
Measured: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Neuropsychiatric Inventory
Measured: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Recollection Task
Measured: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
N-Back
Measured: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Rivermead Behavioral Memory Test
Measured: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Instrumental Activities of Daily Living
Measured: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Functional Capacities for Activities of Daily Living
Measured: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Multifactorial Memory Questionnaire
Measured: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Paul B. Rosenberg, Johns Hopkins University
- Investigators
- Paul B Rosenberg, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212692
- Sponsor's protocol ID
- NA_00039100
- Other IDs
- R01AG034934
- Status last verified
- Dec 2015
- First submitted
- 30 Sep 2010
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theoretically Based Memory Training Intervention in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01212692
- Acronym / sponsor ID
- NA_00039100
- Conditions
- Mild Cognitive Impairment (MCI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Oct 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Oct 2010 (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 learn if activities that challenge the brain (mentally stimulating activities) can improve memory and other types of thinking in patients with Mild Cognitive Impairment. The study will compare the effects of different methods of mental stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentally stimulating activities | Experimental | Behavioral: mentally stimulating activities |
| Mentally stimulating activities- other | Active comparator | Behavioral: mentally stimulating activities |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 50 years of age
- meet criteria for amnestic-Mild Cognitive Impairment (MCI)
- have capacity to give informed consent
- have capacity to complete assessment measures
Key exclusion criteria (6 listed)
- history of drug or alcohol dependence
- severe psychiatric conditions associated with psychosis (e.g., schizophrenia)
- recent stroke
- clinical diagnosis of probable Alzheimer's Disease
- history of seizure disorder, serious head trauma, or other medical, psychiatric, or neurological conditions associated with significant cognitive impairment (e.g., Parkinson's Disease, Korsakoff's, HIV)
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 |
|---|---|---|
| mentally stimulating activitiesThe study will compare the effects of different methods of mental stimulation. The intervention involves 6 classroom-style educational sessions and 10 mental stimulation studies involving computerized memory tasks. | Behavioural | Mentally stimulating activities, Mentally stimulating activities- other |
Primary outcome
Self-Ordered Pointing Task
Time frame: baseline
Trail-Making
Time frame: baseline
Timed Instrumental Activities of Daily Living
Time frame: baseline
Rey Auditory Verbal Learning Test
Time frame: baseline
Self-ordered pointing task
Time frame: immediately after the intervention
Self-ordered pointing task
Time frame: 3 months post intervention
Self-ordered pointing task
Time frame: 9 months post-intervention
Trail-Making
Time frame: immediately after the intervention
Trail-Making
Time frame: 3 months post-intervention
Trail-Making
Time frame: 9 months post-intervention
Timed Instrumental Activities of Daily Living
Time frame: immediately after the intervention
Timed Instrumental Activities of Daily Living
Time frame: 3 months post-intervention
Timed Instrumental Activities of Daily Living
Time frame: 9 months post-intervention
Rey Auditory Verbal Learning Test
Time frame: immediately after the intevention
Rey Auditory Verbal Learning Test
Time frame: 3 months post-intervention
Rey Auditory Verbal Learning Test
Time frame: 9 months post-intervention
12 secondary outcomes
Clinical Dementia Rating Scale
Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Digit Symbol Substitution Test
Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Digit Span
Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Verbal Fluency Test
Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Geriatric Depression Scale
Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Neuropsychiatric Inventory
Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Recollection Task
Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
N-Back
Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Rivermead Behavioral Memory Test
Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Instrumental Activities of Daily Living
Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Functional Capacities for Activities of Daily Living
Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
Multifactorial Memory Questionnaire
Time frame: baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention
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 9 Dec 2015.
Related trials for Mild Cognitive Impairment (MCI)
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
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
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.
Paul B Rosenberg, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mentally stimulating activities in people with Mild Cognitive Impairment (MCI), run by Johns Hopkins University 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 4 inclusion and 6 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 9 Dec 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Self-Ordered Pointing Task (time frame: baseline). The study lists 16 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 9 Dec 2015.