Alzheimer Disease
Conditions
Brief summary
This is a randomized sham control study to evaluate how repetitive Transcranial Magnetic Stimulation (rTMS), interactive cognitive training, or the combination of rTMS and cognitive training reduce the cognitive decline of patients diagnosed with Alzheimer's disease
Detailed description
Participants may be assigned to one of four experimental arms (1-TMS-Stimulation with X-Torp task, 2-TMS-Stimulation with MindMotion Go, 3-TMS-Sham with X-Torp task, 4-TMS-Sham with MindMotion Go.) The study will be conducted in two phases. During Phase 1, participants will be randomized between experimental conditions 1 and 4. Data will be analyzed upon completion of Phase1 and Phase 2 will commence only if there is efficacy in the TMS arm. During Phase2, participants will be randomized to arms 2 and 3.
Interventions
DEVICETMS stimulation with X-Torp task
TMS-Stimulation with X-Torp task
DEVICETMS-Stimulation with MindMotion Go
TMS-Stimulation with MindMotion Go
DEVICETMS-Sham with X-Torp task
TMS-Sham with X-Torp task
DEVICETMS-Sham with MindMotion Go
TMS-Sham with MindMotion Go
Sponsors
Ali Rezai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Male or Female between 50-85 years of age * Able and willing to give informed consent * Probable AD consistent with NIA/AA criteria * Modified Hachinski Ischemia Scale (MHIS) score of \<= 4 * Geriatric Depression Scale (GDS) score of \<= 6 * Mini Mental State Exam (MMSE) score 18-26. The MMSE adjusted scoring instructions may be followed for screening patients as applicable.
Exclusion criteria
* Unstable medical conditions * Visual impairments * Mobility limitations * Cognition-enhancing medication unless on a stable dosage for at least 3 months before the start of the trial. * History of epilepsy or seizure disorder * History of psychosis * Current thoughts of suicidal ideation or self-harm as assessed by the Columbia-Suicide severity rating scale score * Progressive neurological disorder or focal signs of abnormality on neurological exam as conducted by a neurologist (other than current diagnosis of AD) * Tinnitus * Metal implants (excluding dental fillings) * Possible pregnancy * Substance use disorder within the past six months * Have other mental or physical conditions that are inappropriate for study participation at PI's or delegated sub investigator's discretion. * Intake of one or a combination of the drugs that may due to their significant seizure threshold lowering potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Performance | 6 months after completion study procedure | Change in cognitive task performance over time using the total score on the Mini Mental State Examination (range 0-30) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain MRI | 6 months after completion of study procedure compared to screening | Change in brain structure and function over time |
| Memory Performance | 6 months after completion of study procedure compared to screening | Total recall on the California Verbal Learning Test - short form (range 0-36) |
Countries
United States
Outcome results
None listed