Status:
UNKNOWN
Brain Insulin Resistance in Mild Cognitive Impairment
Lead Sponsor:
Turku University Hospital
Conditions:
Alzheimer Disease
Mild Cognitive Impairment
Eligibility:
All Genders
55-80 years
Brief Summary
Alzheimer´s disease (AD) is the most common cause of dementia. The most important risk factor for AD is old age; modifiable risk factors for AD include metabolic risk factors, i.e. diabetes, and obesi...
Detailed Description
Alzheimer´s disease (AD) and other diseases causing dementia have become increasingly important causes of disability in elderly people worldwide. Mainly due to a rise in life-expectancy, the prevalenc...
Eligibility Criteria
Inclusion
- Inclusion criteria for MCI/early AD -patients for the present study are:
- diagnosis of MCI due to AD or early AD based on a neurologist's or a geriatrician's clinical examination and/ or cognitive testing showing either a decline during at least a 6 month follow-up or a slight decline in episodic memory
- clinical dementia rating (CDR) = 0,5, based on an interview with the patient's spouse or close relative
- age 55 to 80 years
- Inclusion criteria for the cognitively unimpaired group for the present study are:
- no subjective cognitive complaints
- consortium to establish a registry for Alzheimer´s Disease (CERAD) test battery at screening visit within the normal range
- clinical dementia rating (CDR) = 0, based on an interview with the study volunteer´s spouse or close relative
- age 55 to 80 years
Exclusion
- Exclusion criteria for both groups are:
- diabetes (type 1 or type 2)
- overweight or obesity (BMI \> 26 kg/m2)
- BMI \< 18 kg/m2
- impaired fasting glucose of impaired glucose tolerance in the 2-hour oral glucose tolerance test, performed at the screening visit
- other major neurological disease than MCI (such as a major stroke, multiple sclerosis, Parkinson's disease). Volunteers with minor neurological diseases such as migraine and a previous transient ischemic attack (TIA) can participate
- major psychiatric illness such as schitzophrenia, bipolar disorder or major depression
- conditions that affect the ability to participate in PET or MRI scanning (cancer diagnosis/ treatment within the last five years, claustrophobia, metal object in the body)
- Exclusion criteria for the MCI/early AD patients only are:
- • amyloid negative PET scan (during the study or performed previously in the clinic or normal beta-amyloid42 or beta-amyloid42/40 ratio in CSF (measured previously in the clinic) (to exclude patients with cognitive decline due to some other pathological process than AD)
Key Trial Info
Start Date :
October 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 10 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06116188
Start Date
October 12 2023
End Date
October 10 2025
Last Update
November 3 2023
Active Locations (1)
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1
Turku PET Centre
Turku, Finland, 20520