E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Psychological processes [F02] |
MedDRA Classification |
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 |
1. To investigate if late depression is associatedwith increased cerebral amyloid deposition, we will carry out a voxel-based comparison of the 18F-flutemetamol images between patients with life depression and healthy controls using a two-sample t test in SPM05.
2. To determine if late life depression with a positive 18F-flutemetamol scan constitutes a prodromal stage of Alzheimer's disease, we will statistically compare the proportion of 18F-flutemetamol-positive LLD subjects, 18F-flutemetamol-negative LDD subjects and 18F-flutemetamol-positive controls who develop AD (NINCDS-ADRDA criteria (McKhann et al, 1984) or amnestic MCI (Petersen et al, 2001) during follow-up. This analysis will be carried out after 2 years of follow-up and yearly thereafter. |
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E.2.2 | Secondary objectives of the trial |
1. To examine the relationship between chronic stress or cotisol levels and amyloid deposition in patients with late life depression, we will correlate self-perceived stress scores and salivary cortisol measurements with 18F-flutemetamol-binding.
2. We will determine whether the clinical phenotype of late life depression is different between 18F-flutemetamol-positive and 18F-flutemetamol-negative patients.
3. We will determine if there are differences in 18F-flutemetamol-binding between patients with early onset depression compared to patients with late onset depression.
4. We will study the effect of aging by dividing our study sample in Three age groups and by comparing amyloid load in relation to cognitive status among these 3 groups.
5. We will determine the effect of ApoE-, 5HTTLPR- and BDNF-genotype on amyloid deposition and on the relationship between cortisol levels and amyloid deposition in patients with late life depression. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. older than 60 years
2. a mjor depressive disorder according to DSM IV criteria
3. a MMSE> ou = 20
4. not primarily referred for assessment of cognitive impairment |
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E.4 | Principal exclusion criteria |
1. anothermajor psychiatric illness
2. alcohol or drug dependence
3. neurologic illness, including stroke, transient ischemic attacks and dementia
4. illness or medication precluding cognitive testing
5. metal implants precluding MRI. Information on prior episodes and age of onset will be obtained from patients and from caregivers.
6. ECT in the last 3 months prior to inclusion.
7. Use of steroids within the last 3 months or other medication interfering with HPA axis. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Conversion to clinically probable Alzheimer's disease over a 10 year follow-up period. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
First time after 2 years, thereafter yearly. |
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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 | 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 | Yes |
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 11 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |