NCT01554475

Brief Summary

So far, no drugs have shown to stop or delay the pathological processes of dementia. Available pharmacological treatment includes a small number of drugs; cholinesterase inhibitors like donepezil, galantamine and rivastigmine, and the NMDA receptor antagonist memantine, all of which only affect the symptoms of the disease. At the same time, alternative medicines like herbal products and dietary supplements are often intensively marketed with the assertion of curative or alleviating effects on dementia. The documentation of clinical effects, side effects and the potential for interaction with prescribed drugs are, however, generally scarce. The aims of this study are to make a survey of the use of alternative medicine in patients with dementia and mild cognitive dysfunction attending the investigators out-patient dementia clinic, and to assess the interaction potential with the patient's other medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Typical duration 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

First Submitted

Initial submission to the registry

January 13, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

2.6 years

First QC Date

January 13, 2012

Last Update Submit

February 16, 2015

Conditions

Keywords

herbal drugsdietary supplementsdrug interactions

Outcome Measures

Primary Outcomes (1)

  • Number of patients taking alternative medicines

    The patient's use of alternative medicine(s) on a given point of time (the consultation date) as reported by the patient or by the next of kin who is the patient's companion during the consultation. The results will be presented as the number of patients taking alternative medicines

    Up to 2 years

Secondary Outcomes (2)

  • Numbers of potential and clinical relevant interactions

    Up to 2 years

  • The patient's subjective experiences with alternative medicines

    up to 2 years

Eligibility Criteria

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

patients diagnosed with dementia, under follow-up at Kløveråsen out-patient clinic

You may qualify if:

  • diagnosed with dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kløveråsen

Bodø, N-8076, Norway

Location

MeSH Terms

Conditions

DementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Trude Giverhaug, PhD

    University Hospital North-Norway

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

March 15, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations