| Cohort Name |
AMyloid imaging for Phenotyping LEwy body dementia |
| Cohort Acronym |
AMPLE |
| DOI |
O'Brien, J. (2017). AMPLE [Data set]. Dementias Platform UK. https://doi.org/10.48532/005000 |
| Study Overview |
The principle aim of AMPLE is to undertake amyloid PET imaging in Lewy Body Dementia (LBD) and Alzheimer's disease (AD) participants and investigate the distribution of amyloid burden in LBD relative to AD and controls at baseline. A further aim is to determine the relationship between amyloid levels at baseline, clinical features of the disease, other imaging changes and subsequent clinical course in follow up. Primary analysis would divide LBD patients into high and low amyloid burden with participants then compared on clinical features with AD-like symptoms and cognitive profiles |
| #Subjects at Baseline |
Target 80 (40 Lewy Body dementia, 20 controls, 20 Alzheimer's disease participants). |
| Institution Name |
Newcastle University |
| Department Name |
Clinical Ageing Research Unit |
| City |
Newcastle |
| Study/Database Website |
http://www.ncl.ac.uk/caru/research/project/5055 |
| Principal Investigator (PI) |
Prof John O'Brien |
| Population Based Study? |
No |
| Family Based Study? |
No |
| Clinical based sample? |
Yes |
| Is there follow-up data available? |
Yes |
| Were participants included prior to development of dementia (may refer to controls only)? |
No |
| Were participants included prior to development of MCI (may refer to controls only)? |
No |
| How is data collected? |
In person |
| Who carries out data collection? |
Interviewers, Clinicians. Clinical Staff |
| Does this take place in participants' homes or at a central location? |
Home and Central |
| Do participants take part individually or are families/partners involved? |
Family: Only as informants. |
| Dementia cases ascertained as part of study: |
Yes |
| Diagnosis based on review of existing clinical data |
Yes |
| Was diagnosis/primary outcomes made blind to exposure variables? |
No |
| How many times followed up? |
1 |
| How regular is follow-up? |
Annually |
| Study start date |
02/04/2013 00:00:00 |
| Is study ongoing? |
Yes |
| Is study still recruiting? |
Yes |
| Inclusion criteria |
All Participants: Age 60+. Sufficient English to carry out cognitive testing. Controls: MMSE greater than or equal to 26. Lewy Body/AD Dementia: MMSE greater than or equal to 12. Meet criteria for probable LBD/AD. If taking anti-cholinesterase drugs or memantine, stable for at least 3 months. Presence of reliable informant sufficient to provide information for informant rated scales. |
| Exclusion criteria |
Concurrent major psychiatric illness (e.g. major depression). Severe physical illness or comorbidity that may limit ability to fully participate in study. Past history of excess alcohol intake. Past history of neurological illness including stroke. Contra-indications for MR or PET. Psychotropic medications which may significantly interfere with cognitive testing (anti- dementia drugs not an exclusion criteria).
Controls: memory complaints or signs/ symptoms of dementia.
Past history of Parkinson's disease. Psychotropic medications which may significantly interfere with cognitive testing (anti- dementia drugs not an exclusion criteria).
Controls: memory complaints or signs/ symptoms of dementia.
Past history of Parkinson's disease. Alzheimer's patients: Past history of Parkinson's disease. All Participants: Contra-indications for MR or PET imaging.Past history of excessive alcohol intake. Past history of other neurological illness including, but not limited to stroke, intracerebral pathology. Psychotropic and other medications which may significantly interfere with cognitive testing (including but not limited to sedative antidepressants, benzodiazepines except low when used as hypnotics, centrally acting anticholinergic drugs). Use of anti dementia drugs (eg anti-cholinesterase drugs or memantine) is not an exclusion criterion.
A relevant history of severe drug allergy or hypersensitivity.
Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, or γ-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial. Receiving any investigational medications, or participation in a trial with investigational medications within the last 30 days. A radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session. |