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New treatment option for Mild Cognitive Impairment
Official title Understanding Brain Mechanisms Involved in Autobiographical Memory
ClinicalTrials.gov ID: NCT05710549
What this study is testing
- What it's testing
- The overall objective of this project is to characterize the spatiotemporal dynamics of brain oscillations underpinning autobiographical memory (ABM) and the modulation of the memory network using non-invasive brain stimulation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Cognitively-Unimpaired Younger and Older Adults
- Age 18 to 35 years old (younger adults)
- Age 55+ years old (older adults)
- without any cognitive impairment (based on the Montreal Cognitive Assessment: MoCA)
- willing and capable to give informed consent for participation in the study after it has been thoroughly explained able
You likely can't join if
- Cognitively-Unimpaired Younger and Older Adults
- any cognitive impairment captured by the Montreal Cognitive Assessment (MoCA) - score \< 26
- major psychiatric co-morbidity including major depressive disorder, schizophrenia, or psychosis
- blindness or other disabilities that prevent task performance
- Contraindication for undergoing MRI
- Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI...
See the full eligibility criteria
- Cognitively-Unimpaired Younger and Older Adults
- Age 18 to 35 years old (younger adults)
- Age 55+ years old (older adults)
- without any cognitive impairment (based on the Montreal Cognitive Assessment: MoCA)
- willing and capable to give informed consent for participation in the study after it has been thoroughly explained able
- willing to comply with all study requirements informed consent form was signed Mild Cognitive Impairment (MCI) patients
- Age 55+ years old
- Clinical Diagnosis of MCI
- Confirmation of diagnosis will be made by the study MD based on a holistic consideration of the participant's cognitive evaluation and history
- Mini-Mental State Examination (MMSE) ≥ 18 (Mild AD ≥ 21)
- CDR ≥ .5
- Demonstration or history of autobiographical memory impairments
- On a stable dose of medications for memory loss including cholinesterase inhibitors (e.g. donepezil, rivastigmine) or memantine as defined as 6 consecutive weeks of treatment at an unchanging dose
- Minimum of completed 8th-grade education
- willing and capable to give informed consent for participation in the study after it has been thoroughly explained - note that to ensure this in the case of the MCI participants, a cut-off of MOCA score \>18 will be...
- able and willing to comply with all study requirements informed consent form was signed
- Cognitively-Unimpaired Younger and Older Adults
- any cognitive impairment captured by the Montreal Cognitive Assessment (MoCA) - score \< 26
- major psychiatric co-morbidity including major depressive disorder, schizophrenia, or psychosis
- blindness or other disabilities that prevent task performance
- Contraindication for undergoing MRI
- Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement) Mild Cognitive Impairment (MCI) patients
- Age \< 55 years old
- Any current diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depressive disorder)
- Other than MCI, any history of other progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tubular sclerosis) or acquired neurological disease (e.g. stroke, traumatic brain injury...
- History of head trauma resulting in prolonged loss of consciousness
- Current history of poorly controlled headaches including chronic medication for migraine prevention
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, or immediate (1st-degree relative) family history of epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a...
- Any unstable medical condition or chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.) or...
- contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted...
- Contraindication for undergoing MRI or receiving tACS
- Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement)
- Any devices such as a pacemaker, medication pump, nerve stimulator, TENS unit, ventriculoperitoneal shunt unless cleared by the responsible covering MD
The study team makes the final eligibility decision.
Where it's taking place
- Geneva, Canton of Geneva, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Geneva, Canton of Geneva, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.