Alzheimer Disease Clinical Trial
— tDCS-ADOfficial title:
Effects at 12 Weeks of Transcranial Direct Current Stimulation on the Cognitions of People Presenting Early Alzheimer's Disease (tDCS-AD)
TDCS is a rapidly expanding technique, used to treat cognitive difficulties associated with many pathologies (Parkinson's disease, rehabilitation after head trauma, etc.), but which remains of the field of research. Its use remains very experimental, and concerns the exploration of cognitions, in healthy and diseased subjects. There are not many studies on the elderly subject with Alzheimer's disease, nor do they document the medium- and long-term effect (more than one month), nor the effect on geriatric parameters such as Fragility indices and the risk of falls, especially at home. These characteristics are decisive because they define the level of autonomy. The investigators therefore wish to study the effect of a 2-week treatment with tDCS (tDCS active) versus placebo (2-week tDCS group) for a three-month period.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 6, 2024 |
Est. primary completion date | June 6, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - A man or woman with probable Alzheimer's disease diagnosed according to the criteria of the National Institute of Neurological and Communicative Disorders Association (NINCDS-ADRDA) - Age = 60 years - Mini Mental State Examination = 18 - Clinical Demential Rating = 1 - Availability of a caregiver for assessments - Patient care in Day Hospital - Informed consent of the subject or his legal representative - General somatic state consistent with study procedures Exclusion Criteria: - Presentation of contraindications to tDCS (presence of intracranial metal implants, intracranial hypertension, comitial risk). - In case of anticholinesterase treatment: taken for at least 6 months and at a non stable dose for 4 months. - Taking an antagonist treatment of NMDA receptors (anodic and cathodic) which cancels post-stimulation effects (memantine). - Other types of dementia or neurological disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 (dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease, Huntington's disease, stroke, major head trauma, cerebral neoplasia, systemic disease ...) , Which can lead to alterations in the functioning of the central nervous system. - psychiatric disorder according to DSM-5, other than Alzheimer's disease including amnestic disorders, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, major depressive episode in progress, psychosis, panic attacks, post traumatic stress disorder And / or cognitive impairment not otherwise specified. - Any other disorder for which treatment is given priority over the treatment of Alzheimer's disease or is likely to interfere with the study treatment or impairing adherence. - Accommodation in an institution (EHPAD, EHPA) or request in progress. - Participation in other biomedical research during the study that may interfere with the objectives of the study. - Person who had a recent change (<1 month) of psychotropic treatment. - Person with a place of residence more than 80 km away. - Person without health insurance. |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Esquirol | Limoges |
Lead Sponsor | Collaborator |
---|---|
Benjamin CALVET |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparing between the active tDCS group with the placebo tDCS group, the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) score, 12 weeks after the start of the course, in subjects with early Alzheimer's disease | difference of ADAS-Cog psychometric scale score between sham and stimulation groups | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04044495 -
Sleep, Rhythms and Risk of Alzheimer's Disease
|
N/A | |
Completed |
NCT04079803 -
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
|
Phase 2 | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT04520698 -
Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
|
N/A | |
Active, not recruiting |
NCT04606420 -
Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
|
N/A | |
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Terminated |
NCT03672474 -
REGEnLIFE RGn530 - Feasibility Pilot
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
Recruiting |
NCT04949750 -
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
|
N/A | |
Recruiting |
NCT05557409 -
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
|
Phase 3 | |
Recruiting |
NCT05288842 -
Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
|
||
Completed |
NCT06194552 -
A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07
|
Phase 1 | |
Completed |
NCT03239561 -
Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
|
Early Phase 1 | |
Completed |
NCT03184467 -
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Terminated |
NCT03487380 -
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT05328115 -
A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease
|
Phase 1 | |
Completed |
NCT05562583 -
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
|
N/A |