Apathy in DementiaPhase 3APA-ADNCT01047254
Bupropion for the Treatment of Apathy in Alzheimer's Dementia
A Phase 3 study testing Elontril in people with Apathy in Dementia, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Apathy in dementia prevents successful application of non-pharmacological treatments, accelerates cognitive and functional decline and increases disease-related costs by earlier need for full-time care. Apathy is a distinct entity and occurs independently of other neuropsychiatric syndromes, like depression. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Apathy in Dementia
- What is being tested?
- Elontril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jul 2014
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate Alzheimer's dementia, male and female (NINCDS/ADRDA criteria)
- Presence of clinically relevant apathy defined by the Neuropsychiatric Inventory (NPI) apathy item (score of >/= 4 points) and the Marin/Starkstein criteria for apathy
- MMSE: 10-25
- Outpatient status, not institutionalized
- Presence of reliable caregiver
- Stable treatment with antidementia drugs for at least three months prior to entry or no treatment with antidementia drugs
Who cannot join
- Other Dementia (e.g. vascular dementia, Lewy-body dementia, fronto-temporal dementia)
- Presence of a clinically relevant depression defined by either the NPI depression item (score >/= 4 points) or DSM-IV criteria for major depressive episode (with depressed mood)
- Alcoholism and Benzodiazepine addiction
- Current treatment with antipsychotics and antidepressants (including St. John's wart)
- Current treatment with dopaminergic agents or Amantadin
- Current treatment with benzodiazepines
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- Current treatment with MAO inhibitor (Bupropion contraindication)
- Known sensibility to Bupropion treatment
- Severe psychiatric disease (including hospitalization) in the last 6 months, suicide attempt, acute psychotic symptoms
- Severe physical illness, that do not allow a participation in a 12-week period of treatment
- Medical history with seizures
- Medical history with tumors of the central nervous system
- Severe craniocerebral injury and medical history with cerebral substance defect
- Clinically relevant renal disease, liver insufficiency
- Simultaneous treatment, which reduces the seizure threshold (e.g. antipsychotics, antidepressants, antimalarial agents, Tramadol, Theophyllin, systemic steroids in higher dose, Chinolone, sedative antihistamines)
- Simultaneous treatment, which is metabolized through Cytochrom P450-Isoenzym 2D6 (e.g. these beta blockers: Metoprolol, Proanolol, Timolol, Carvediol, Nebivolol, Typ-1C-Antiarrhyhtmics for e.g. Propafenon, Flecinid) (except Donepezil and Galantamin)
- Simultaneous treatment with drugs, which may interfere with the metabolization of Bupropion (e.g. Carbamazepin, Phenytoin, Valproat, Ritonavir, Lopinavir)
- Diabetes mellitus, which is therapeutically poorly regulated and treated by medication
- Treatment with stimulants and appetite depressants
- Participation in other clinical trials with in the last 3 months
- Suicidal tendency
- Known lactose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Bupropion for the Treatment of Apathy in Alzheimer's Dementia(Apa-AD)
Apathy in dementia prevents successful application of non-pharmacological treatments, accelerates cognitive and functional decline and increases disease-related costs by earlier need for full-time care. Apathy is a distinct entity and occurs independently of other neuropsychiatric syndromes, like depression.
Today, there is no high-level evidence for any effective treatment of apathy in AD. In contrast to other neuropsychiatric syndromes in AD, like psychosis and depression, and despite its high prevalence and clinical relevance, apathy has never been the primary outcome in a clinical trial. Basic and clinical research has provided a distinct model of the pathophysiology of apathy with dopamine and norepinephrine as the key neurotransmitter systems involved. The antidepressant Bupropion is a dopamine and norepinephrine reuptake inhibitor. There is evidence from case-series, that Bupropion reduces apathy in patients with organic brain disorders. This study will test the efficacy and safety of Bupropion in the treatment of apathy in AD in a 12-week multicenter doubleblind placebo controlled trial. Secondary endpoints will be quality of life of patients, caregivers' distress, ability of patients to perform activities of daily living,utilization of healthcare resources by patients and by caregivers, and cognitive functions.
- Conditions
- Apathy in Dementia
- Being tested
- Elontril, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElontrilDrug
flexible dose of Bupropion 150-300 mg
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Active comparator | Buproprion 150-300 mg in a flexible dose Receives: Drug: Elontril |
| placebo capsule | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apathy Evaluation Scale (AES) score
Measured: 12 weeks
Secondary outcomes (1)
NPI total score;NPI caregivers' distress total score;ADCS-ADL; QoL-AD; RUD;ADAScog;MMSE
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJan 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 Apathy in DementiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cologne, Physician of neurology, psychiatry and psychotherapy Horn, MD; Bad Honnef, Charite University, Berlin, Germany, Universität Duisburg-Essen, University of Erlangen-Nürnberg, University of Freiburg, University Medical Center Goettingen, Universität des Saarlandes, Johannes Gutenberg University Mainz, Heidelberg University, Philipps University Marburg, Ludwig-Maximilians - University of Munich, University of Rostock, University Hospital Tuebingen, University of Ulm
- Responsible party
- Principal investigator, Frank Jessen, University Hospital, Bonn
- Investigators
- Frank Jessen, MD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047254
- Sponsor's protocol ID
- 2007-005352-17
- Acronym
- APA-AD
- Status last verified
- May 2017
- First submitted
- 11 Jan 2010
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Bupropion for the Treatment of Apathy in Alzheimer's Dementia(Apa-AD)
- ClinicalTrials.gov ID
- NCT01047254
- Acronym / sponsor ID
- APA-AD / 2007-005352-17
- Conditions
- Apathy in Dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- University of Cologne, Physician of neurology, psychiatry and psychotherapy Horn, MD; Bad Honnef, Charite University, Berlin, Germany, Universität Duisburg-Essen, University of Erlangen-Nürnberg, University of Freiburg, University Medical Center Goettingen, Universität des Saarlandes, Johannes Gutenberg University Mainz, Heidelberg University, Philipps University Marburg, Ludwig-Maximilians - University of Munich, University of Rostock, University Hospital Tuebingen, University of Ulm
- Study start
- Jan 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Jan 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.
Apathy in dementia prevents successful application of non-pharmacological treatments, accelerates cognitive and functional decline and increases disease-related costs by earlier need for full-time care. Apathy is a distinct entity and occurs independently of other neuropsychiatric syndromes, like depression.
Today, there is no high-level evidence for any effective treatment of apathy in AD. In contrast to other neuropsychiatric syndromes in AD, like psychosis and depression, and despite its high prevalence and clinical relevance, apathy has never been the primary outcome in a clinical trial. Basic and clinical research has provided a distinct model of the pathophysiology of apathy with dopamine and norepinephrine as the key neurotransmitter systems involved. The antidepressant Bupropion is a dopamine and norepinephrine reuptake inhibitor. There is evidence from case-series, that Bupropion reduces apathy in patients with organic brain disorders. This study will test the efficacy and safety of Bupropion in the treatment of apathy in AD in a 12-week multicenter doubleblind placebo controlled trial. Secondary endpoints will be quality of life of patients, caregivers' distress, ability of patients to perform activities of daily living,utilization of healthcare resources by patients and by caregivers, and cognitive functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupropion | Active comparator | Drug: ElontrilBuproprion 150-300 mg in a flexible dose |
| placebo capsule | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mild to moderate Alzheimer's dementia, male and female (NINCDS/ADRDA criteria)
- Presence of clinically relevant apathy defined by the Neuropsychiatric Inventory (NPI) apathy item (score of >/= 4 points) and the Marin/Starkstein criteria for apathy
- MMSE: 10-25
- Outpatient status, not institutionalized
- Presence of reliable caregiver
Key exclusion criteria (22 listed)
- Other Dementia (e.g. vascular dementia, Lewy-body dementia, fronto-temporal dementia)
- Presence of a clinically relevant depression defined by either the NPI depression item (score >/= 4 points) or DSM-IV criteria for major depressive episode (with depressed mood)
- Alcoholism and Benzodiazepine addiction
- Current treatment with antipsychotics and antidepressants (including St. John's wart)
- Current treatment with dopaminergic agents or Amantadin
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 |
|---|---|---|
| Elontrilflexible dose of Bupropion 150-300 mg | Drug | Bupropion |
| placebo | Drug | placebo capsule |
Primary outcome
Change in Apathy Evaluation Scale (AES) score
Time frame: 12 weeks
1 secondary outcome
NPI total score;NPI caregivers' distress total score;ADCS-ADL; QoL-AD; RUD;ADAScog;MMSE
Time frame: 12 weeks
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 May 2017.
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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.
Frank Jessen, MD principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Elontril in people with Apathy in Dementia, run by University Hospital, Bonn 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 6 inclusion and 22 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 May 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in Apathy Evaluation Scale (AES) score (time frame: 12 weeks). 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 May 2017.