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Completed

NCT Number: NCT01554475

Use of Alternative Medicine in 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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Nervous System Diseases Neurocognitive Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Kløveråsen

Bodø, N-8076, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed with dementia

Treatment and study plan

Primary outcomes

  1. Number of patients taking alternative medicines

    Time frame: Up to 2 years

    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

Secondary outcomes

  1. Numbers of potential and clinical relevant interactions

    Time frame: Up to 2 years

    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.

  2. The patient's subjective experiences with alternative medicines

    Time frame: up to 2 years

    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.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Kløveråsen Center for dementia, Bodø

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 15, 2012
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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