Amnestic Mild Cognitive ImpairmentOutPreC MCINCT01525368
Outcome Predictors of a Cognitive Intervention in aMCI
An observational study of Amnestic Mild Cognitive Impairment, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Cognitive training has been shown to be successful in patients with amnestic mild cognitive impairment (aMCI), a group at high-risk for Alzheimer's disease (AD). Moreover, in a randomized controlled trial, the investigators recently found that aMCI patients receiving a cognitive intervention showed stable… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amnestic Mild Cognitive Impairment
- What is being tested?
- cognitive intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Jul 2014
- Phase
- Observational
- 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
Study population: Consecutive aMCI patients of an University-based memory clinic
Who may be able to join
- male or female patients, fulfilling Petersen´s criteria of amnestic mild cognitive impairment (aMCI)
- No evidence for other psychiatric axis I disorders according to DSM-IV criteria.
- No evidence for neurological disorders (e.g. stroke)
- No uncontrolled arterial hypertension or diabetes mellitus
- No history of drug / alcohol abuse
- The patient is able to provide written informed consent to participate in the study.
- for the cognitive-reserve-study patients, a high (low) cognitive reserve is defined as a verbal IQ score of >/= 120 (</= 110) as assessed by the MWT-B, a German multiple vocabulary test
Who cannot join
- Evidence for acute psychiatric or neurological disorders
- Uncontrolled arterial hypertension or diabetes mellitus
- History of drug / alcohol abuse
- No ability to participate and no willing to give informed consent and comply with the study restrictions.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Stroke and Dementia Research, Campus Grosshadern, Ludwig-Maximilian University
Munich, 81377
About this study
Official title: Outcome Predictors of a Complex Cognitive Intervention in Amnestic Mild Cognitive Impairment (aMCI)
Cognitive training has been shown to be successful in patients with amnestic mild cognitive impairment (aMCI), a group at high-risk for Alzheimer's disease (AD). Moreover, in a randomized controlled trial, the investigators recently found that aMCI patients receiving a cognitive intervention showed stable hypometabolism in FDG-PET, whereas patients in an active control group showed pronounced hypometabolism on follow-up scans in regions typically affected in AD.
Previous studies indicate that not all patients respond equally well to a cognitive intervention. Identifying factors that predict response to treatment could help selecting patients for a targeted intervention. A potentially important predictor is cognitive reserve defined as premorbid cognitive performance. The hypothesis is that different levels of cognitive reserve (high cognitive reserve vs. low cognitive reserve) have different neurostructural and neurofunctional correlates and influence treatment response in a different way. Moreover, the impact of white matter lesions on treatment effects will be investigated.
Read more
The investigator will perform a complex cognitive training program. Forty patients with aMCI (20 with high cognitive reserve, 20 with low cognitive reserve) will be recruited in this study. Since the patients are recruited consecutively, an estimated overall number of 80 will be included and receive the training of whom about 40 will meet the inclusion criteria for our cognitive-reserve-study (high or low cognitive reserve). Data of the whole group will be used to analyze the potential impact of white matter lesions on response to the intervention. Cognitive effects of the intervention will be evaluated by neuropsychological testing. Neurofunctional and neurostructural changes depending on cognitive reserve will be measured using resting state fMRI and diffusion tensor imaging (DTI).
For comparison, a group of 30 aMCI patients will be recruited as an active control group receiving study investigations (neuropsychological testing as well as MRIs), and exercises for self-study at home, not the complex cognitive intervention.
- Conditions
- Amnestic Mild Cognitive Impairment
- Being tested
- cognitive intervention
- Keywords
- mild cognitive impairment, Alzheimer's disease, cognitive intervention, cognitive reserve
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive interventionBehavioural
Complex modular cognitive intervention focussing on memory aspects (e.g. internal memory strategies, external memory aids), other cognitive functions (e.g. attention) as well as social interactions.
| Study group | Role | What they receive |
|---|---|---|
| cognitive intervention group | Not described Receives: Behavioral: cognitive intervention | |
| active control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in California Verbal Learning Test
Measured: month 0 and month 6
Change in overall cognition (ADAScog)
Measured: month 0 and month 6
Change in Face-Name Learning Test
Measured: month 0 and month 6
Secondary outcomes (7)
Change in appraisal of quality of life (SF-36)
Measured: month 0 and 6
Change in neurofunctional MRT (resting state fMRI)
Measured: month 0 and 6
Change in depression scores (Beck Depression Inventory)
Measured: month 0 and month 6
Change in working memory (Digit Span)
Measured: month 0 and month 6
Change in attention (Trail Making Test)
Measured: month 0 and month 6
Change in executive functions (Stroop Test)
Measured: month 0 and month 6
Change in neurostructural MRI (diffusion tensor imaging)
Measured: month 0 and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startSep 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amnestic 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katharina Buerger, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525368
- Sponsor's protocol ID
- cogT002
- Acronym
- OutPreC MCI
- Status last verified
- Nov 2014
- First submitted
- 24 Jan 2012
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Predictors of a Complex Cognitive Intervention in Amnestic Mild Cognitive Impairment (aMCI)
- ClinicalTrials.gov ID
- NCT01525368
- Acronym / sponsor ID
- OutPreC MCI / cogT002
- Conditions
- Amnestic Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, Alzheimer's disease, cognitive intervention, cognitive reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 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.
Cognitive training has been shown to be successful in patients with amnestic mild cognitive impairment (aMCI), a group at high-risk for Alzheimer's disease (AD). Moreover, in a randomized controlled trial, the investigators recently found that aMCI patients receiving a cognitive intervention showed stable hypometabolism in FDG-PET, whereas patients in an active control group showed pronounced hypometabolism on follow-up scans in regions typically affected in AD.
Previous studies indicate that not all patients respond equally well to a cognitive intervention. Identifying factors that predict response to treatment could help selecting patients for a targeted intervention. A potentially important predictor is cognitive reserve defined as premorbid cognitive performance. The hypothesis is that different levels of cognitive reserve (high cognitive reserve vs. low cognitive reserve) have different neurostructural and neurofunctional correlates and influence treatment response in a different way. Moreover, the impact of white matter lesions on treatment effects will be investigated.
The investigator will perform a complex cognitive training program. Forty patients with aMCI (20 with high cognitive reserve, 20 with low cognitive reserve) will be recruited in this study. Since the patients are recruited consecutively, an estimated overall number of 80 will be included and receive the training of whom about 40 will meet the inclusion criteria for our cognitive-reserve-study (high or low cognitive reserve). Data of the whole group will be used to analyze the potential impact of white matter lesions on response to the intervention. Cognitive effects of the intervention will be evaluated by neuropsychological testing. Neurofunctional and neurostructural changes depending on cognitive reserve will be measured using resting state fMRI and diffusion tensor imaging (DTI).
For comparison, a group of 30 aMCI patients will be recruited as an active control group receiving study investigations (neuropsychological testing as well as MRIs), and exercises for self-study at home, not the complex cognitive intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive intervention group | – | Behavioral: cognitive intervention |
| active control group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive aMCI patients of an University-based memory clinic
Key inclusion criteria (7 listed)
- male or female patients, fulfilling Petersen´s criteria of amnestic mild cognitive impairment (aMCI)
- No evidence for other psychiatric axis I disorders according to DSM-IV criteria.
- No evidence for neurological disorders (e.g. stroke)
- No uncontrolled arterial hypertension or diabetes mellitus
- No history of drug / alcohol abuse
Key exclusion criteria (4 listed)
- Evidence for acute psychiatric or neurological disorders
- Uncontrolled arterial hypertension or diabetes mellitus
- History of drug / alcohol abuse
- No ability to participate and no willing to give informed consent and comply with the study restrictions.
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 interventionComplex modular cognitive intervention focussing on memory aspects (e.g. internal memory strategies, external memory aids), other cognitive functions (e.g. attention) as well as social interactions. | Behavioural | cognitive intervention group |
Primary outcome
Change in California Verbal Learning Test
Time frame: month 0 and month 6
Change in overall cognition (ADAScog)
Time frame: month 0 and month 6
Change in Face-Name Learning Test
Time frame: month 0 and month 6
7 secondary outcomes
Change in appraisal of quality of life (SF-36)
Time frame: month 0 and 6
Change in neurofunctional MRT (resting state fMRI)
Time frame: month 0 and 6
Change in depression scores (Beck Depression Inventory)
Time frame: month 0 and month 6
Change in working memory (Digit Span)
Time frame: month 0 and month 6
Change in attention (Trail Making Test)
Time frame: month 0 and month 6
Change in executive functions (Stroop Test)
Time frame: month 0 and month 6
Change in neurostructural MRI (diffusion tensor imaging)
Time frame: month 0 and month 6
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 13 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amnestic Mild Cognitive Impairment, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 7 inclusion and 4 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 13 Nov 2014. 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 Germany. 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?
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?
Change in California Verbal Learning Test (time frame: month 0 and month 6). The study lists 3 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 13 Nov 2014.