Psychological and Electrophysiological Correlates of dementia with Lewy bodies and Parkinson's disease dementia
| ISRCTN | ISRCTN58368984 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58368984 |
| Protocol serial number | 10/10/2005 |
| Sponsor | King's College London (UK) |
| Funder | King's College London (UK) |
- Submission date
- 02/06/2006
- Registration date
- 15/09/2006
- Last edited
- 25/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Clive Ballard
Scientific
Scientific
King's College London
Wolfson CARD
Guy's Campus
London
SE1 1UL
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Within-subjects comparison design testing a possible healthcare intervention where the sequence in which the different forms of care received are randomised. |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised, repeated measures investigation of rhythmic auditory cues as a potential intervention for attentional fluctuations in dementia with Lewy bodies (DLB)/Parkinson's disease dementia (PDD) |
| Study acronym | PECFC |
| Study objectives | Dementia with Lewy bodies (DLB) accounts for 15% - 20% of late onset dementia whilst Parkinson's disease occurs in 1% of individuals over the age of 65; with at least 50% of these individuals developing symptoms of dementia (Parkinson's disease dementia - PDD). In addition to memory problems, people with these conditions experience persistent hallucinations, parkinsonian symptoms, marked problems with attention and fluctuating consciousness. Other symptoms that occur commonly include repeated falls, faints, temporary loss of consciousness, delusions and Rapid Eye Movement (REM) sleep behaviour disorder. Rhythmic auditory cues can regulate attentional processes and fluctuating cognition in patients suffering from DLB or Parkinson's Disease Dementia (PDD) as reflected by a decrease in reaction time standard deviation variability in attentional tasks. |
| Ethics approval(s) | South London and Maudsley NHS trust approved of protocol on 22 November 2005 (ref. no.: 05/Q0706/264). |
| Health condition(s) or problem(s) studied | Dementia |
| Intervention | Baseline versus rhythmic auditory cue versus rhythmic auditory cue at increased volume - a one-off assessment comparing patients baseline performance with performance under different experimental conditions. |
| Intervention type | Other |
| Primary outcome measure(s) |
Reaction time standard deviation, measured at intervention. |
| Key secondary outcome measure(s) |
Measured at intervention: |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 64 |
| Key inclusion criteria | 1. Operationalised diagnosis of Dementia with Lewy Bodies (DLB), Parkinsons Disease with Dementia (PDD), mild possible or probable Alzheimers Disease (AD), or Parkinsons Disease (PD) 2. DLB and PDD patients must show clear signs of fluctuating cognition as indicated by a score eqaulling six on the One Day Fluctuation Assessment 3. Severity of dementia must be mild to moderate (Mini Mental State Examination [MMSE] greater than 14) 4. Capacity to give informed consent for participating in the study or Assent from Next of Kin (NOK) 5. Able to complete computerised test battery and understand instructions 6. Good hearing 7. Aged 63 - 89 years, either sex |
| Key exclusion criteria | 1. Symptoms or disabilities that would result in difficulties fulfilling the test requirements 2. Any diagnosis of another medical condition that in the eyes or the experimentor or investigator would prohibit partaking in the study 3. Ability to undergo 12 hour washout period from anti-parkinsonian medication before cognitive testing |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
King's College London
London
SE1 1UL
United Kingdom
SE1 1UL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
24/05/2018: No publications found, verifying study status with principal investigator.
01/03/2016: No publications found, verifying study status with principal investigator.
