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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554475
• Other study ID #: 2011/1705(REK)
• Status: Completed
• Phase: N/A
• First received: January 13, 2012
• Last updated: February 16, 2015
• Start date: March 2012
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Data Protection Authority
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosed with dementia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Dementia

Locations

Country	Name	City	State
Norway	Kløveråsen	Bodø

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	Kløveråsen Center for dementia, Bodø

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Numbers of potential and clinical relevant interactions	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.	Up to 2 years	No
Secondary	The patient's subjective experiences with alternative medicines	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.	up to 2 years	No