E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with mild to severe Alzheimer's dementia and/or vascular dementia with behavioural disturbances, with at least agitation, aggression or aberrant motor disturbances. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with mild to severe dementia, type Alzheimer's or vascular who suffer from behavioral disturbances, with at least agitation, aggression or aberrant motor disturbances. |
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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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012271 |
E.1.2 | Term | Dementia Alzheimer's type |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057678 |
E.1.2 | Term | Vascular dementia |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033371 |
E.1.2 | Term | Pain |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012267 |
E.1.2 | Term | Dementia |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066842 |
E.1.2 | Term | Behavioural and psychiatric symptoms of dementia |
E.1.2 | System Organ Class | 10037175 - Psychiatric 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 |
The primary objective is to evaluate the efficacy of Namisol® behavioural disturbances, such as agitation, aggression and aberrant motor disturbances in patients with dementia, when added to a treatment with acetaminophen. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of Namisol® on other secondary outcome measures, such as quality of life and functioning in daily activities.
- To evaluate safety of Namisol® as assessed with physical examination, effects on cognitive functioning and adverse event monitoring.
- To evaluate the efficacy of Namisol® pain intensity.
- For the subgroup of subjects suffering from pain: to evaluate the efficacy of Namisol® on pain intensity |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subject has possible or probable dementia, type AD, VaD or AD/VaD, according to the criteria of NINCDS-ADRDA/NINCDS-AIREN or based on an expert panel decision.
- Clinical Dementia Rating (CDR) score 1 to 3 (mild to severe dementia).
- Clinically relevant behavioural disturbances existing at least one month prior to screening, defined as a score of ≥ 10 on the NPI, including presence of the domain agitation/aggression or motor disturbance.
- Informed consent by the subject and subject’s informal caregiver.
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E.4 | Principal exclusion criteria |
- Dementia other than AD, VaD or AD/VaD
- Major psychiatric disorder
- History of, or current drug abuse.
- Current alcohol abuse or unwillingness to use no more than 2 alcoholic consumptions daily
- Severe (and/or unstable) concomitant or intercurrent illness
- Clinical or biochemical evidence of liver disease (ALT or AST ≥ twice the upper limit of normal) or known allergy to acetaminophen.
- Use of tricyclic antidepressants (TCA), carbamazepine or fluoxetine.
- Changes in dosage of antipsychotics, benzodiazepines or cholinesterase inhibitors within 2 weeks prior to intervention.
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E.5 End points |
E.5.1 | Primary end point(s) |
Neuropsychiatric Inventory (NPI) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At screening, baseline (T=0), T=2 weeks (by telephone interview) and T= 3 weeks. |
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E.5.2 | Secondary end point(s) |
- Verbal Rating Scale (VRS)
- Pain Assessment Checklist for Seniors with Limited Ability to Communicate Dutch version (PACSLAC-D)
- Caregiver Clinical Global Impression of Change (CCGIC)
- Cohen-Mansfield Agitation Inventory (CMAI)
- Barthel Index
- Quality of Life Alzheimer's disease (QoL-AD)
- Paired Associates Learning test (PAL WMS-R)
- Safety parameters: vital signs, physical examination, ECG, adverse events etc. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All outcome measurements will be assessed at baseline (T= 0) and T= 3 weeks.
The VRS will also be assessed at screening and follow up (phone call) and daily in a study medication diary.
CCGIC will also be assessed at T= 2 weeks (by phone call interview)
Adverse events will be recorded from signing informed consent onwards |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 2 |
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 | No |
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
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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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |