E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Apathy in Alzheimer's Disease |
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E.1.1.1 | Medical condition in easily understood language |
Apathy in Alzheimer's Disease |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001896 |
E.1.2 | Term | Alzheimer's disease |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy and safety of Bupropion in the treatment of apathy in Alzheimer’s dementia.
Primary hypothesis: Bupropion reduces the score on the Apathy Evaluation Scale (AES) as compared to a placebo group in Alzheimer’s dementia patients with apathy. |
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E.2.2 | Secondary objectives of the trial |
Secondary hypotheses (to be evaluated by means of exploratory statistical methods): Bupropion compared with placebo treatment (1) improves overall neuropsychiatric syndromes, (2) reduces caregivers’ distress related to neuropsychiatric syndromes, (3) improves the patients’ ability to perform activities of daily living, (4) improves quality of life of patients, (5) reduced utilization of healthcare resources by patients and by caregivers, (6) improves cognition of patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Key inclusion criteria:
• Mild to moderate Alzheimer’s dementia, male and femal(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
• Age: 55-90
• Outpatient status, not institutionalized
• Presence of reliable caregiver
• Stable treatment with antidementia drugs for at least three months |
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E.4 | Principal exclusion criteria |
Key exclusion criteria:
• Presence of a clinically relevant depressed mood defined by either the NPI depression item (score >/= 4 points) or DSM-IV criteria for major depressive episode (with depressed mood)
• Treatment with antipsychotics (may interfere with the Bupropion
mechanism of action)
• Treatment with antidepressants (may interfere with the Bupropion
mechanisms of action)
• Treatment with dopaminergic agents (may interfere with the Bupropion mechanism of action)
• Treatment with MAO inhibitor (Bupropion contraindication)
• Other contraindications to Bupropion treatment |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in Apathy Evaluation Scale (AES) score 12 weeks after randomization |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Quality of life, cognition and activities of daily living |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial is the last visite of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |