E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dementia and cognitive impairment; in particular mild cognitive impairment and Alzheimer's disease |
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E.1.1.1 | Medical condition in easily understood language |
Dementia or cognitive impairment; i.e. diseases that typically cause memory problems that the patient and/or relatives have noticed. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
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 | 10009846 |
E.1.2 | Term | Cognitive impairment |
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066571 |
E.1.2 | Term | Progression of Alzheimer's disease |
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 | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10001897 |
E.1.2 | Term | Alzheimer's disease (incl subtypes) |
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 examine the efficacy of raised [18F]Flutemetamol brain uptake for differentiating subjects with mild cognitive impairment (MCI), who subsequently will develop Alzheimer’s disease (AD), from patients with MCI who will be cognitively stable or develop other dementias than AD. |
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E.2.2 | Secondary objectives of the trial |
To study whether raised [18F]Flutemetamol brain uptake is associated with other markers associated with prodromal AD, such as hippocampal atrophy, episodic memory dysfunction and cerebrospinal fluid biomarkers in patients with MCI.
To specifically examine whether raised [18F]Flutemetamol brain uptake is associated with changes of monomeric and oligomeric forms of β-amyloid in cerebrospinal fluid.
To study the frequency of raised [18F]Flutemetamol brain uptake in cognitively healthy elderly individuals, with no signs of early AD. To determine whether cognitively healthy elderly individuals with raised [18F]Flutemetamol brain uptake will develop AD in the future.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy elderly subjects (Nomas study) - No cognitive symptoms reported by study participant - Normal performance on cognitive tests - General cognition and functional performance preserved such that a diagnosis of MCI or dementia cannot be made by physician at the time of the baseline visit - Between 60 and 90 years of age - Fluent in Swedish - Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing.
Mild cognitive impairment (TiDiS study) - Cognitive symptoms reported by patient and/or informant - Between 60 and 80 years of age - Mini-Mental State Exam score between 24 and 30 - General cognition and functional performance sufficiently preserved such that a diagnosis of dementia cannot be made by physician at the time of the baseline visit - Fluent in Swedish - Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing.
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E.4 | Principal exclusion criteria |
Exclusion Criteria (for both MCI and healthy elderly): - Major depression as described in DSM-IV. - History of schizophrenia or other recurrent psychotic disorder - History of alcohol or substance abuse or dependence within the past 5 years - Diseases that will make study participation difficult, such as terminal cancer or significant heart failure. - Certain neurologic diseases, such as Huntington's disease, normal pressure hydrocephalus, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
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E.5 End points |
E.5.1 | Primary end point(s) |
Visual Detection of Raised [18F] Flutemetamol Uptake in patients with mild cognitive impairment (MCI) or healthy volunteers (HV) |
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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) |
[18F] Flutemetamol brain:cerebellar uptake ratios measured with a priori VOI analysis in subjects with MCI compared to HV.
Associations of [18F]Flutemetamol brain uptake rations measured by VOI analysis with other diagnostic methods, including CSF biomarkers, cognitive tests and MRI findings.
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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 | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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This trial ends with the last visit of the last subject/patient. The participants to this study are recruited from two on-going studies that will continue. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |