Amyloid imaging in late life depression

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-018064-95-BE

Enrollment

120

Registered

2012-05-22

Start date

2012-06-18

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late life depression

Interventions

Product Name: Flutemetamol (18F) Product Code: Flutemetamol (18F) Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Conversion to clinically probable Alzheimer's disease over a 10 year follow-up period.;Timepoint(s) of evaluation of this end point: First time after 2 years, thereafter yearly.	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Conversion to clinically probable Alzheimer's disease over a 10 year follow-up period.;Timepoint(s) of evaluation of this end point: First time after 2 years, thereafter yearly.

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Countries

Belgium

Contacts

Public ContactMathieu Vandenbulcke

University Leuven

mathieu.vandenbulcke@uzleuven.be3216346790

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 21, 2026