Skip to main content
Clinical Trials/NCT05168098
NCT05168098
Completed
Not Applicable

Impact of the Olfactory Stimulation on the People With Mild Dementia Via the Horticultural Therapy

National Taiwan Normal University1 site in 1 country28 target enrollmentOctober 1, 2019
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
National Taiwan Normal University
Enrollment
28
Locations
1
Primary Endpoint
ImmunoMaggnetic-Reduction (IMR) blood tests
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study is to examine the effect of the olfactory stimulation intervention on the people with mild to moderate dementia. We recruit 28 participants who has been diagnosed with mild to moderate dementia from 2 day care centers in Taipei. They are randomly assigned to three groups, including the olfactory intervention group, game comparison group, and control group. Beside the control group, the participant with two other groups were required to attend twelve weeks intervention (twice a week, thirty minutes for one section). Every participants completed the olfactory test, both paper-pencil and computer-based examination for cognition, blood test and psychological measurement before and after the intervention. The results showed that the participant in olfactory intervention group significant improved score in the LOTCA-G examination, and the Aβ1-42 concentration of the blood test significant increase in the control group; furthermore, the olfactory intervention group is lowest concentration among three groups in the Tau concentration of the blood test via ANCOVA analysis.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
January 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ages \>50 years with a diagnosis of mild or moderate dementia
  • being admitted to the day care center and living in the community
  • being willing to do blood test with a family member's consent.

Exclusion Criteria

  • experience in chronic rhinitis or sinusitis, which causes loss of smell; inability to perform the cognitive exam or olfactory test (e.g., having a severe hearing impairment)
  • inability to attend group activities due to severe emotional or aggressive behaviors

Outcomes

Primary Outcomes

ImmunoMaggnetic-Reduction (IMR) blood tests

Time Frame: 60 min

A registered nurse drew 5 cc of blood from each participant twice, including pretest and posttest by the following procedure: Step 1: Plasma preparation 10-ml K3 EDTA tubes were used for collecting blood, immediately followed by gently inverting each blood tube 10 times. Blood tubes were centrifuged at room temperature at 2500g for 15 minutes with an aid of a swing-out (backet) rotor. Every 1-ml plasma (supernatant) was transferred to a fresh 1.5-ml eppendorf using a disposable 1-ml micropipette tip. All the plasma samples were frozen at -80 °C before measurements. Step 2: Assays of plasma biomarkers IMR kits were used in assaying amyloid B 1-42 and tau protein (Tau). For assaying AB1-42, 60-ul reagent was mixed with 60-ul plasma. For assaying Tau, 80-ul reagent was mixed with 40-ul plasma. Duplicated measurements were conducted for each biomarker per plasma sample. The average value of the duplicated measured concentrations is reported.

Secondary Outcomes

  • Mini-mental State Examination(60 min.)
  • The Top International Biotech Smell Identification Test (TIBSIT)(60 min.)
  • Geriatric Depression Scale (GDS-15)(60 min.)
  • Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)(60 min.)

Study Sites (1)

Loading locations...

Similar Trials