Use of Alternative Medicine in Patients With Dementia and Mild Cognitive Dysfunction

This study is currently recruiting participants.
Verified May 2012 by University Hospital of North Norway
Sponsor:
Collaborator:
Kløveråsen Center for dementia, Bodø
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01554475
First received: January 13, 2012
Last updated: May 6, 2012
Last verified: May 2012

January 13, 2012
May 6, 2012
March 2012
October 2014   (final data collection date for primary outcome measure)
Number of patients taking alternative medicines [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01554475 on ClinicalTrials.gov Archive Site
  • Numbers of potential and clinical relevant interactions [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Assessment of the potential of interactions between the patient's alternative medicines and prescribed or over-the-counter drugs in use at the date of the consultation. The assessment will be based on data from litterature reports. Results will be presented as numbers of potential and clinical relevant interactions.
  • The patient's subjective experiences with alternative medicines [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    In the interview the patients will be asked to tell if they have experienced positive, negative, or no effects related to their use of alternative medicines. Results will be presented as number of patients.
Same as current
Not Provided
Not Provided
 
Use of Alternative Medicine in Patients With Dementia and Mild Cognitive Dysfunction
Use of Alternative Medicine Among Patients With Dementia and Mild Cognitive Dysfunction

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.

Patients: All patients with a diagnosis of dementia under follow-up at the out-patient clinic are invited to participate, if giving a written consent.

Method: a semi-structured interview is undertaken by the doctor at the end of the consultation. Patients and their company are asked to name their alternative medicines (if any), for how long the products have been used, where and how they learned about the products, ant to tell about their experiences with the products (i.e if they have noticed effects or side-effects). After the consultation information of the the actual product's contents and properties are obtained and an assessment of possible interactions with the patient's other drugs (prescriptions and self-reported use of over-the-counter drugs) is made. Reported effects or side-effects are registered.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Dementia
  • Cognitive Impairment
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosed with dementia
Both
Not Provided
No
Contact: Hilde Risvoll, MD +47 90095535 hilde.monica.risvoll@nordlandssykehuset.no
Norway
 
NCT01554475
2011/1705(REK)
No
University Hospital of North Norway
University Hospital of North Norway
Kløveråsen Center for dementia, Bodø
Study Chair: Trude Giverhaug, PhD University Hospital North-Norway
University Hospital of North Norway
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP