NCT01505504

Brief Summary

Weight loss is a frequent problem associated with Alzheimers disease (AD). Mirtazapine has weight loss as a frequent side effect. The aim of this retrospective study is to check whether mirtazapine 30 mg (once daily) can counteract weight loss in patients with AD or mixed dementia (AD + vascular).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

7.8 years

First QC Date

January 4, 2012

Last Update Submit

January 5, 2012

Conditions

Alzheimer's DiseaseWeight LossMixed DementiaDementia

Outcome Measures

Primary Outcomes (1)

  • body weight

    6 months

Interventions

mirtazapineDRUG

30 mg at bedtime

Also known as: Remergon

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with established diagnosis of AD or mixed dementia with reported weight loss

You may qualify if:

  • AD or mixed dementia
  • documented weight loss
  • mirtazapine 30 mg explicitly prescribed against weight loss

You may not qualify if:

  • no treatment compliance
  • other causes of weight loss
  • other interventions against weight loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Alzheimer DiseaseWeight LossMixed DementiasDementia

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 6, 2012

Study Start

January 1, 2004

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

January 6, 2012

Record last verified: 2012-01

Locations

BE(1)