Alzheimer DiseaseMeynD-DBSNCT01094145
Deep Brain Stimulation (DBS) of the Nucleus Basalis Meynert (NBM) to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease
A study testing Deep brain stimulation in people with Alzheimer Disease, run by University of Cologne at 1 site in Germany.
Trial summary
In the study at hand, six patients with light to moderate Alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Deep brain stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jan 2013
- Phase
- Interventional
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- German speaking male/female subjects
- age:60-80
- AD assessed by DSM-IV, ICD-10 and NINCDS-ADRDA-Scale
- no Lewy-Body-dementia or other form of dementia
- MMST >18 and <26
- stable psychopharmacological medication
Show all 12Show fewer
- no psychotic symptoms, no suicidal tendency
- education for at least 8 years
- written informed consent of the patient
- consent of at least two family members
- no contraindication regarding PET-examination
- no contraindication regarding anesthesia or stereotactic operation
Who cannot join
- legal accommodation
- clinical co-morbidity
- contraindication of MRT examination
- psychotic symptoms last six months
- aggressive behavior or suicidal tendency
- verbal IQ <85
Show all 9Show fewer
- stereotactic operation in previous history
- neoplastic neurological diseases
- serious organic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Brain Stimulation of the Nucleus Basalis Meynert to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease
In the study at hand, six patients with light to moderate Alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert.
Read the detailed description
In the study at hand, six patients with light to moderate Alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert. The stereotactic implantation of the electrodes will be guided by computerized tomography (CT) and magnetic resonance tomography (MRT).
Basically, even though deep brain stimulation is an invasive method, there are only few side effects. Surgical risks correspond with the risk of DBS in morbus Parkinson or other movement disorders (0,4-6%).
After the baseline examination, the patients will be implanted with the electrodes; accordingly all follow-ups are accomplished postoperative. From the second week after the operation, the conventional stimulation takes place as a doubleblind, randomized change between ON and OFF periods. Modifications of the stimulation parameter to obtain the best possible result are possible.
Throughout the one-year observation-period, the patients will be followed closely to monitor the effects of DBS on their cognitive abilities, psychopathological well being, the quality of life, praxie and nutritional condition using standardized neurological and psychiatric rating scales.
- Conditions
- Alzheimer Disease
- Being tested
- Deep brain stimulation
- Keywords
- (light to moderate)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationOther
DBS in the Nucleus basalis Meynert
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Sham comparator | Stimulator setting is OFF Receives: Other: Deep brain stimulation |
| Deep Brain Stimulation | Active comparator | Stimulator setting is ON Receives: Other: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive improvement
improving cognitive outcome parameters assessed by a series of standardized neuropsychological tests
Measured: one- year
Secondary outcomes (1)
determination of the optimal stimulation parameter
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Kuhn, University of Cologne
- Investigators
- Volker Sturm, MD, Principal investigator, University of CologneJens Kuhn, MD, Principal investigator, University of CologneH. J. Freund, Prof. Dr. med., Principal investigator, Stellvertretender Leiter der Klinischen Prüfung Institut für Neurowissenschaften und Medizin (INM-7) Forschungszentrum Jülich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094145
- Sponsor's protocol ID
- UK-09157
- Acronym
- MeynD-DBS
- Status last verified
- Jun 2013
- First submitted
- 25 Mar 2010
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baldermann JC, Schuller T, Huys D, Becker I, Timmermann L, Jessen F, Visser-Vandewalle V, Kuhn J. Deep Brain Stimulation for Tourette-Syndrome: A Systematic Review and Meta-Analysis. Brain Stimul. 2016 Mar-Apr;9(2):296-304. doi: 10.1016/j.brs.2015.11.005. Epub 2015 Dec 29.
PubMed 26827109
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of the Nucleus Basalis Meynert to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01094145
- Acronym / sponsor ID
- MeynD-DBS / UK-09157
- Conditions
- Alzheimer Disease
- Keywords
- (light to moderate)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Mar 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.
In the study at hand, six patients with light to moderate Alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert.
Detailed description
In the study at hand, six patients with light to moderate Alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert. The stereotactic implantation of the electrodes will be guided by computerized tomography (CT) and magnetic resonance tomography (MRT).
Basically, even though deep brain stimulation is an invasive method, there are only few side effects. Surgical risks correspond with the risk of DBS in morbus Parkinson or other movement disorders (0,4-6%).
After the baseline examination, the patients will be implanted with the electrodes; accordingly all follow-ups are accomplished postoperative. From the second week after the operation, the conventional stimulation takes place as a doubleblind, randomized change between ON and OFF periods. Modifications of the stimulation parameter to obtain the best possible result are possible.
Throughout the one-year observation-period, the patients will be followed closely to monitor the effects of DBS on their cognitive abilities, psychopathological well being, the quality of life, praxie and nutritional condition using standardized neurological and psychiatric rating scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Sham comparator | Other: Deep brain stimulationStimulator setting is OFF |
| Deep Brain Stimulation | Active comparator | Other: Deep brain stimulationStimulator setting is ON |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- German speaking male/female subjects
- age:60-80
- AD assessed by DSM-IV, ICD-10 and NINCDS-ADRDA-Scale
- no Lewy-Body-dementia or other form of dementia
- MMST >18 and <26
Key exclusion criteria (9 listed)
- legal accommodation
- clinical co-morbidity
- contraindication of MRT examination
- psychotic symptoms last six months
- aggressive behavior or suicidal tendency
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 |
|---|---|---|
| Deep brain stimulationDBS in the Nucleus basalis Meynert | Other | Deep Brain Stimulation, Placebo |
Primary outcome
cognitive improvement
Time frame: one- year
improving cognitive outcome parameters assessed by a series of standardized neuropsychological tests
1 secondary outcome
determination of the optimal stimulation parameter
Time frame: one year
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 7 Jun 2013.
- Derived from this study: PubMed 26827109Baldermann JC, Schuller T, Huys D, Becker I, Timmermann L, Jessen F, Visser-Vandewalle V, Kuhn J. Deep Brain Stimulation for Tourette-Syndrome: A Systematic Review and Meta-Analysis. Brain Stimul. 2016 Mar-Apr;9(2):296-304. doi: 10.1016/j.brs.2015.11.005. Epub 2015 Dec 29.
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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.
Volker Sturm, MD principal investigator
University of Cologne
Jens Kuhn, MD principal investigator
University of Cologne
H. J. Freund, Prof. Dr. med. principal investigator
Stellvertretender Leiter der Klinischen Prüfung Institut für Neurowissenschaften und Medizin (INM-7) Forschungszentrum Jülich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Alzheimer Disease, run by University of Cologne 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 12 inclusion and 9 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 7 Jun 2013. 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. Some participants in this study may receive a placebo. 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?
cognitive improvement (time frame: one- year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01094145, which also lists 1 linked publication.
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 7 Jun 2013.