Dementia of the Alzheimer TypePhase 4ECIFNCT01329601
Effect of Cognitive Intervention in Alzheimer's Disease (AD) on Functional Cortical Networks in fMRI
A Phase 4 study testing StaCog, stage specific cognitive Intervention and booklet based training in people with Dementia of the Alzheimer Type, run by University of Rostock at 1 site in Germany.
Trial summary
The study aims to detect the effect of a structured cognitive rehabilitation program, teh stage specific intervention STACog, on cognitive performance and functional activation in fMRI in a group of patients with mild cognitive impairment and dementia due to Alzheimer's disease compared to a waiting group control… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia of the Alzheimer Type
- What is being tested?
- StaCog, stage specific cognitive Intervention and booklet based training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2011
- Phase
- Phase 4
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Mild Cognitive Impairment, Amnestic type (single domain) according to Petersen criteria or a low grade AD according to ICD-10/NINCDS-ADRDA
Who cannot join
- Major depression
- severe visual and acoustic impairment
- severe physical impairments
- known malignancy
- laboratory elevated inflammatory markers (ESR, CRP, leukocytes)
- stroke
Show all 10Show fewer
- brain trauma
- epilepsy
- previous participation in a memory training
- patients receiving drug treatment (antidepressants, neuroleptics, anti-dementia, other brain performance enhancing drugs) at least three months prior to study initiation for the duration of the project are at a stable dosage
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry, University of Rostock
Rostock, Mecklenburg-Vorpommern, 18147
Stefan J. Teipel, Prof. Dr., 0049-381-494 ext. 9471, stefan.teipel@med.uni-rostock.de
Stefan J. Teipel, Prof. Dr.
About this study
Official title: Effect of the Stage Specific Cognitive Intervention Program on Functional Cortical Activation in Alzheimer's Disease
The study aims to detect the effect of a structured cognitive rehabilitation program, teh stage specific intervention STACog, on cognitive performance and functional activation in fMRI in a group of patients with mild cognitive impairment and dementia due to Alzheimer's disease compared to a waiting group control sample. Baseline performance in cognitive tests and fMRI will further be assessed compared to healthy control subjects.
Read the detailed description
Subject of the proposed project is to offer based on existing theoretical principles and methods stage-related, reproducible, relevant to everyday life group training in German for people with aMCI and slightly severe AD and compared with a - in terms of goal variables - to be less effective prestigious intervention . It is believed that the "active treatment" - in the intervention group, the overall level of functioning can longer be maintained and that positive transfer effects on non-cognitive level - to achieve and cognitive level - here at nationals. In addition, information is expected that the conversion rate of people with dementia and aMCI cut to a further loss of independence in humans can be delayed slightly with severe AD. The project aims to provide data to estimate the effect sizes of intervention can be determined on the basis of group size and duration of ongoing investigations.
Involving functional imaging measures, the intervention study, an adequate platform for the detection of intervention effects on neurobiological basis using fMRI dar. Here, the cerebral blood flow in specific activation as a measure of neuronal and synaptic activity and integrity both in cross-section of a subsample of healthy elderly people studied determined and changes in cerebral activity patterns in people with severe AD, aMCI or slightly in comparison pre-/post interventions. There are detectable much earlier in the pathogenesis of functional changes as structural, using fMRI, the study is to make a significant contribution to prove whether a modular cognitive intervention altered neural and synaptic activity and whether this change is accompanied by an improvement in cognitive performance.
A complete and proven effectiveness of cognitive group training could make a significant contribution that people with MCI and severe AD easily submit their own initiative mental condition, and add itself to sustain the intellectual, emotional and social potential. As a long-term perspective, the results for the optimization of cognitive intervention programs and continue to implement the organizations of the open and contribute stationary the elderly and specialized medical facilities and other medical facilities.
- Conditions
- Dementia of the Alzheimer Type
- Being tested
- StaCog, stage specific cognitive Intervention, booklet based training
- Keywords
- cognitive training, Alzheimer disease, tertiary prevention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StaCog, stage specific cognitive InterventionBehavioural
Also called Cognitive rehabilitation
StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI
booklet based trainingBehavioural
Also called Active behavioural control
Home based training of episodic memory using paper-pencil exercizes
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Intervention | Experimental | StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI Receives: Behavioral: StaCog, stage specific cognitive Intervention |
| Booklet-based training | Active comparator | Home based training of episodic memory using paper-pencil exercizes Receives: Behavioral: booklet based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
California Verbal Learning Test
Cognitive test for episodic memory
Measured: Detecting changes between two different time points (baseline and 6 months)
Secondary outcomes (1)
functional cortical activity in fMRI
Measure of cortical activation during n-back letter recognition with emotional modulation
Measured: Detecting changes between two different time points (baseline and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia of the Alzheimer TypeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- DZNE, German Center for Neurodegenerative Disorders, Germany
- Investigators
- Stefan J. Teipel, Prof. Dr., Principal investigator, Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329601
- Sponsor's protocol ID
- Int_HRO_1
- Acronym
- ECIF
- Status last verified
- Jan 2011
- First submitted
- 1 Apr 2011
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Stage Specific Cognitive Intervention Program on Functional Cortical Activation in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01329601
- Acronym / sponsor ID
- ECIF / Int_HRO_1
- Conditions
- Dementia of the Alzheimer Type
- Keywords
- cognitive training, Alzheimer disease, tertiary prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Collaborators
- DZNE, German Center for Neurodegenerative Disorders, Germany
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 6 Apr 2011 (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 study aims to detect the effect of a structured cognitive rehabilitation program, teh stage specific intervention STACog, on cognitive performance and functional activation in fMRI in a group of patients with mild cognitive impairment and dementia due to Alzheimer's disease compared to a waiting group control sample. Baseline performance in cognitive tests and fMRI will further be assessed compared to healthy control subjects.
Detailed description
Subject of the proposed project is to offer based on existing theoretical principles and methods stage-related, reproducible, relevant to everyday life group training in German for people with aMCI and slightly severe AD and compared with a - in terms of goal variables - to be less effective prestigious intervention . It is believed that the "active treatment" - in the intervention group, the overall level of functioning can longer be maintained and that positive transfer effects on non-cognitive level - to achieve and cognitive level - here at nationals. In addition, information is expected that the conversion rate of people with dementia and aMCI cut to a further loss of independence in humans can be delayed slightly with severe AD. The project aims to provide data to estimate the effect sizes of intervention can be determined on the basis of group size and duration of ongoing investigations.
Involving functional imaging measures, the intervention study, an adequate platform for the detection of intervention effects on neurobiological basis using fMRI dar. Here, the cerebral blood flow in specific activation as a measure of neuronal and synaptic activity and integrity both in cross-section of a subsample of healthy elderly people studied determined and changes in cerebral activity patterns in people with severe AD, aMCI or slightly in comparison pre-/post interventions. There are detectable much earlier in the pathogenesis of functional changes as structural, using fMRI, the study is to make a significant contribution to prove whether a modular cognitive intervention altered neural and synaptic activity and whether this change is accompanied by an improvement in cognitive performance.
A complete and proven effectiveness of cognitive group training could make a significant contribution that people with MCI and severe AD easily submit their own initiative mental condition, and add itself to sustain the intellectual, emotional and social potential. As a long-term perspective, the results for the optimization of cognitive intervention programs and continue to implement the organizations of the open and contribute stationary the elderly and specialized medical facilities and other medical facilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Intervention | Experimental | Behavioral: StaCog, stage specific cognitive InterventionStaCog intervention to improve cognitive performance and activities of daily living in AD and MCI |
| Booklet-based training | Active comparator | Behavioral: booklet based trainingHome based training of episodic memory using paper-pencil exercizes |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of Mild Cognitive Impairment, Amnestic type (single domain) according to Petersen criteria or a low grade AD according to ICD-10/NINCDS-ADRDA
Key exclusion criteria (10 listed)
- Major depression
- severe visual and acoustic impairment
- severe physical impairments
- known malignancy
- laboratory elevated inflammatory markers (ESR, CRP, leukocytes)
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 |
|---|---|---|
| StaCog, stage specific cognitive InterventionAlso: Cognitive rehabilitationStaCog intervention to improve cognitive performance and activities of daily living in AD and MCI | Behavioural | Cognitive Intervention |
| booklet based trainingAlso: Active behavioural controlHome based training of episodic memory using paper-pencil exercizes | Behavioural | Booklet-based training |
Primary outcome
California Verbal Learning Test
Time frame: Detecting changes between two different time points (baseline and 6 months)
Cognitive test for episodic memory
1 secondary outcome
functional cortical activity in fMRI
Time frame: Detecting changes between two different time points (baseline and 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
Related trials for Dementia of the Alzheimer Type
RecruitingPhase 2
A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease
Dementia, Alzheimer's Type, Alzheimer's Disease
Active, not recruiting
Effectiveness of Strength-based Intervention for Elderly With Dementia Living in the Community
Dementia, Mild Cognitive Impairment
Active, not recruitingPhase 2/3
Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease
Dementia Moderate, Dementia, Mild
RecruitingObservational study
Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis
Neurodegenerative Diseases, Dementia
Recruiting
The Effect of Combination of Mediterranean Diet and Oleocanthal in Patients With Mild Cognitive Impairment
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.
Stefan J. Teipel, Prof. Dr. principal investigator
Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing StaCog, stage specific cognitive Intervention and booklet based training in people with Dementia of the Alzheimer Type, run by University of Rostock 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 1 inclusion and 10 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 6 Apr 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Stefan J. Teipel, Prof. Dr. (0049-381-494 ext. 9471, stefan.teipel@med.uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
California Verbal Learning Test (time frame: Detecting changes between two different time points (baseline and 6 months)). 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 6 Apr 2011; AzTrials last refreshed its copy on 7 Nov 2026.