Investigating brain insulin resistance in mild cognitive impairment and Alzheimer's disease
Brain Insulin Resistance in Mild Cognitive Impairment
Turku University Hospital · NCT06116188
This study is testing if brain insulin resistance is linked to memory problems in people with mild cognitive impairment and early Alzheimer's disease compared to those without these issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 55 Years to 80 Years |
| Sex | All |
| Sponsor | Turku University Hospital (other gov) |
| Locations | 1 site (Turku) |
| Trial ID | NCT06116188 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between brain insulin resistance and cognitive decline in individuals with mild cognitive impairment (MCI) and early Alzheimer's disease (AD). It employs a hyperinsulinemic-euglycemic clamp technique to measure insulin resistance in the central nervous system, which is believed to be linked to cognitive impairment. The study will compare patients diagnosed with MCI or early AD to cognitively unimpaired individuals, assessing their cognitive function and insulin sensitivity. The findings could provide insights into whether insulin resistance is an independent risk factor for cognitive decline and dementia.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 55 to 80 with a diagnosis of mild cognitive impairment due to Alzheimer's disease or early Alzheimer's disease.
Not a fit: Patients with diabetes or those who are overweight or obese may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of the role of insulin resistance in cognitive decline, potentially guiding future therapeutic strategies for Alzheimer's disease.
How similar studies have performed: Previous studies have suggested a link between insulin resistance and cognitive decline, indicating that this approach may yield valuable insights, though it is still an area of ongoing investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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)
Where this trial is running
Turku
- Turku PET Centre — Turku, Finland (RECRUITING)
Study contacts
- Principal investigator: Laura Ekblad, MD — Turku PET Centre
- Study coordinator: Laura Ekblad, MD
- Email: llekbl@utu.fi
- Phone: 02 3130000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Disease, Mild Cognitive Impairment, Positron Emission Tomography