Status:
RECRUITING
Acute Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity
Lead Sponsor:
University Department of Geriatric Medicine FELIX PLATTER
Collaborating Sponsors:
McMaster University
Conditions:
MCI
SCD
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
The primary objectives of this pilot study are to test if a single dose of an oral ketone monoester supplement will increase blood flow and connectivity in the brain in adults with subjective cognitiv...
Detailed Description
In this non-randomized, single-arm study participants will undergo a baseline MRI scan to assess functional connectivity in the DMN and resting CBF without ketone supplementation. Participants will th...
Eligibility Criteria
Inclusion
- Adults aged 55 years or older
- Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI)
- SCD CRITERIA:
- Self-experienced, persistent decline of cognitive abilities within the last 5 years in relation to a previously normal status
- Normal results on demographically adjusted standardized cognitive tests
- Accompanied by concerns associated with SCD and a feeling of worse performance than others in the same age group
- Decline must not be related to a specific event or explained by a specific disease, medical disorder, medication, or substance abuse
- MCI CRITERIA
- Fulfils criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5):
- Demographically adjusted performance between -1 and -2 SD below average in one or more cognitive domains on standardized cognitive tests
- Accompanied by concern from the individual, a knowledgeable informant, or clinician indicating mild cognitive decline
- Capacity for independent daily activities is maintained
Exclusion
- Clinical diagnoses of psychiatric disorders (e.g., anxiety disorders, depression)
- Diagnosed major neurocognitive disorder (i.e., dementia)
- Association of SCD or MCI with delirium
- Diagnosed cardiometabolic disease (Uncontrolled hypertension (systolic blood pressure \>160 mm Hg, and/or diastolic blood pressure \>100 mm Hg, Type 2 diabetes)
- Substance use disorder
- History of heart attack or stroke requiring hospitalization in the past 3 years
- MRI contraindications, including implanted medical devices
- Experiencing residual fatigue, brain fog, or tiredness post-acute illness (i.e., long-COVID)
- Severe literacy, visual, hearing, and/or speech impairment that would make participation in the study difficult or impossible
- Individuals who are not fluent in Swiss German or German
Key Trial Info
Start Date :
April 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06962501
Start Date
April 12 2025
End Date
November 1 2025
Last Update
May 8 2025
Active Locations (1)
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1
University Hospital of Basel
Basel, Canton of Basel-City, Switzerland, 4031