Investigate the degree of association between the level of AGE*s and the development and progression of paratonia in Alzheimer*s Disease (AD).Research questions are:(1) Are elevated levels of AGE*s, at baseline and during 12 months follow-up,…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Movement disorders (incl parkinsonism)
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) The presence of paratonia will be assessed with the Paratonia Assessment
Instrument (PAI)
2) The severity of present paratonia, assessed with the Modified Ashworth Scale
(MAS)
Explanatory endpoint) the skin tissue levels of Advanced Glycation Endproducts
(N*-CML & Pentosidine), determined by skin autofluorescence (AGE-reader).
Secondary outcome
1) The patient*s functional mobility, assessed with the Timed Up and Go (TUG)
2) Quality of life will be assessed with the QoL-AD
3) Activities of Daily living (ADL) assessed with the Groningen Activity
Restriction Scale (GARS) and the Barthel Index
4) Daily activity level will be assessed with the pedometer
Patients* characteristics at baseline: Gender, age, date of dementia diagnosis,
comorbidity (chart diagnosis, including the presence of diabetes mellitus) and
the use of medication, global deterioration stage (GDS) [Reisberg 1982] and
Mini Mental State Examination (MMSE) [Folstein 1975].
Background summary
PARAGE
Paratonia (PAR) and Advanced Glycation Endproducts (AGE)
A study by lectoraat Transparante Zorgverlening Hanze University of Aplied
sciences Groningen funded by Alzheimer Netherlands
Paratonia is a distinctive form of hypertonia in Alzheimers Disease (AD). This
type of hypertonia can already be present in the early stage of AD causing
movement disorders and has a negative impact on the functional mobility. This
decline of functional mobility has been identified as a significant risk factor
for falls in dementia. Paratonia is present in almost all patients in the
later/severe stages of AD (prevalence 90-100% Souren 1997, Hobbelen 2006) and
movement becomes almost impossible with a further loss of mobility, severe
contractures and pain resulting in a decrease of the quality of life.
The pathogenesis of paratonia is not well understood and there are currently no
effective interventions against paratonia. Recently we found that patients in
early stage dementia and with Diabetes Mellitus (DM) had a significantly higher
risk for the development of paratonia in comparison with those without DM
(OR=10.7). [Hobbelen 2011] Interestingly, both AD and Diabetes Mellitus are
related to higher serum concentrations of Advanced Glycation Endproducts
(AGE*s). Therefore we hypothesize that increased AGE levels are associated with
the development and progression of paratonia
If the hypothesis of an association between AGE*s and paratonia is true, new
pathways can be explored in unravelling the pathophysiology of paratonia as
well as new possibilities to prevent or postpone paratonia.
With a strong association next trials can target on AGE*s and study if
paratonia is influenced by this. Novel insight opens new possibilities with
possibly new and relatively simple low-costs treatment methods to target
paratonia such as prevention of further accumulation, cleavage of already
formed AGE*s or AGE inhibition with drug targeting AGE levels possibly in
combination with physiotherapy(Meerwaldt 2008) This could results in great
advantages for both patients and caregivers and at the long-term health care
costs.
Study objective
Investigate the degree of association between the level of AGE*s and the
development and progression of paratonia in Alzheimer*s Disease (AD).
Research questions are:
(1) Are elevated levels of AGE*s, at baseline and during 12 months follow-up,
associated with a higher incidence of paratonia?
(2) Are elevated levels of AGE*s, at baseline and during 12 months follow-up,
associated with the severity of and worsening of paratonia?
(3) Are elevated levels of AGE*s, at baseline and during 12 months follow-up,
associated with the impairment and deterioration of functional status, mobility
and quality of life?
Study design
A longitudinal observational cohort study with a 1-year follow-up in patients
with dementia in day-care centers.
Study burden and risks
A total of 3 assessments will be performed at the day-care centers; at
baseline, and after 6 and 12 months.
Every assessment will last approximately 20 minutes per participant and
consists of measuring skinlevel AGE'S with a non invasive AGE reader,
functional fysical tests (often part of usual assessment by physiotherapists)
and filling in a questionair (QOL=AD)
Eyssoniusplein 18
Groningen 9714 CE
NL
Eyssoniusplein 18
Groningen 9714 CE
NL
Listed location countries
Age
Inclusion criteria
- Community dwelling patients with Alzheimer's Disease (AD) , with an established diagnosis according to the NINCDS-ARDRA criteria visiting day-care facilities.
- Able to walk 10 meters unassisted (walking aid is allowed)
- A GDS Reisberg score of 2,3,4 or 5 (the GDS Reisberg is a 7-point scale indicating the severity of cognitive and functional decline in Alzheimer*s disease, from 1= No subjective complaints of memory deficits to 7= Basic psychomotor skills and verbal ability are lost and require assistance in toileting and feeding)
- Having a plain colored skin (Caucasian)(due to the limitations of the AGE-reader device)
Exclusion criteria
- Established diagnosis of dementia type other than AD or mixed forms like AD and vascular dementia or AD and Parkinson*s disease
- Using psychotropic drugs, as these drugs can possibly mimic paratonic rigidity.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43641.042.13 |