None listed
Conditions
Brief summary
The study will provide a full cognitive assessment of patients with MCI to confirm their diagnosis and likely underlying cause. There are three specific aims of the project: 1. Establish a cohort of well-characterised patients with neurodegenerative diseases presenting as mild cognitive impairment (MCI). 2. Create a repository of blood, brain imaging (MRI & PET) and CSF data for biomarker studies. 3. Implement a clinical model to increase physician referrals to clinical trials, through access to advanced imaging, neurocognitive screening, and cognitive neurologist assessments for people residing in the South Eastern part of Melbourne and rural areas in Victoria. The study will allow us the opportunity to collect a large database of MCI patients to gain greater insights in to risks, diagnosis and prognosis of the disease. Simultaneously it will provide patients with a clearer understanding of their disease (through use of research only tools) and increase referrals in to clinical trials of potentially beneficial treatments for patients with MCI.
Interventions
Participants will undergo a series of clinical and neuroimaging tests and assessments to better understand the cause of their mild cognitive impairment (MCI)
These will include an FDG PET scan (250Mbq, intravenous, one time) 20 min scan duration
Amyloid PET scan (285Mbq, intravenous, one time) 20 min scan duration
A range of cognitive tests - Mini-Mental Status Examination (MMSE); clinical dementia rating scale (CDR); addenbrookes cognitive examination III (ACE-III); weschler menory scale (WMS,
Participants will undergo a series of clinical and neuroimaging tests and assessments to better understand the cause of their mild cognitive impairment (MCI) These will include an FDG PET scan (250Mbq, intravenous, one time) 20 min scan duration Amyloid PET scan (285Mbq, intravenous, one time) 20 min scan duration A range of cognitive tests - Mini-Mental Status Examination (MMSE); clinical dementia rating scale (CDR); addenbrookes cognitive examination III (ACE-III); weschler menory scale (WMS, 4th edition) visual reproduction subtest; WMS (revised edition) verbal paired associated subtest; weschler adult intelligence scale (4th edition) similarities, digit span, coding and block design subtests; test of premorbid function; controlled oral word association test (COWAT); category fluency test; boston naming test (2nd edition); victoria stroop test; clock drawing test; rey complex figure test, copy trial; hayling test; examination of practice; sentence repetition test and pyramids and palm trees test. These will be conducted over a single administration, testing session expected to last 2-3 hours MRI (30 min) A single blood sample for standard laboratory blood tests A single blood sample for exploratory biomarkers An optional CSF sample for exploratory biomarkers Overall study duration will be 3-6 weeks (dependent on the availability of imaging appointments) Imaging will be performed by qualified and certified nuclear medicine technologists/radiographers. Cognitive tests will be performed by neuropsychology registrars Blood sampling will be performed by research nurses Optional CSF sampling will be performed by anaesthesiologists or neurology fellows
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 30-85 years 2. At least 6 years of education 3. Adequate English, visual & auditory acuity to complete cognitive testing 4. Reliable study partner 5. Subjective and objective cognitive impairment consistent with MCI 6. Potentially interested in participation in therapeutic drug trials
Exclusion criteria
1. Lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder. 2. Current major depressive episode or a past history of major depressive disorder with a high risk of relapse in the opinion of the investigator 3. Current drug or alcohol abuse/dependence. 4. History of alcohol abuse/dependence within 2 years of the onset of the symptoms of cognitive impairment. 5. Participants with a history of cancer (other than skin or in situ prostate cancer) within the previous 5 years. 6. Any significant disease or unstable medical condition that could affect cognitive testing or longevity (i.e., chronic renal failure, chronic hepatic disease, severe pulmonary disease). 7. Other neurological illness, including clinically significant stroke or Parkinson’s disease. A history of stable epilepsy is not an exclusion criterion. 8. Participants in whom magnetic resonance imaging (MRI) is contraindicated.
Outcome results
None listed