The purpose of this research study is to test the safety, possible side effects, and possible effectiveness of mesenchymal stem cell infusions when given to people with a diagnosis of mild to moderate Alzheimer's disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Umbilical cord-derived, allogeneic hMSC administered intravenously at a dose of approximately 100 million cells per infusion.
University of Miami
Miami, Florida, United States
Number of Incidence of any Treatment-Emergent Serious Adverse Events (TE-SAEs)
All adverse events will be evaluated by the investigator for relationship with the study intervention. Treatment-Emergent Serious Adverse Events is defined as any untoward medical occurrence with a reasonable possibility that it is caused by the study intervention that: * Is life-threatening (e.g.; leads to stroke or non-fatal pulmonary embolism); * Requires inpatient hospitalization or prolongation of existing hospitalization; * Results in persistent or significant disability/incapacity * Results in other clinically significant sign(s) or symptom(s), (e.g.; clinically asymptomatic brain microhemorrhages); or * Results in death
Time frame: One month post-infusion
Cognitive function over time as assessed by the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog 11)
The ADAS-Cog 11 is a 13-item version of ADAS-Cog comprising of the original 11-item ADAS-Cog as well as Delayed Recall and Digit Cancellation items. The total score ranges from 0-85 points, with a lower score indicating better performance.
Time frame: Up to Week 65
Cognitive function over time as assessed by the Mini Mental State Examination (MMSE) of Folstein test
The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The total score ranges from 0-30, with a higher score indicating better cognitive performance.
Time frame: Up to Week 65
Depressive symptoms over time as assessed by the Geriatric Depression Scale (GDS) Short Version
The GDS is a 15-item questionnaire with each item counting as one point. The total score ranges from 0 to 15 with a score greater than 5 indicating possible depression.
Time frame: Up to Week 65
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Participant quality of life over time assessed via Alzheimer's Disease Related Quality of Life (ADRQL-40) Questionnaire as completed by the caregiver
ADRQL-40 is a questionnaire completed by the caregiver assessing the quality of life of the participant with AD. The total score for the ADRQL is computed by summing the values assigned to the responses, dividing the sum by the maximum value for the scale and multiplying the results by 100 to obtain a percentage score of 0 to 100. A higher score reflects a higher quality of life.
Time frame: Up to Week 65
Participant quality of life over time as assessed via the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Questionnaire as completed by the caregiver
The ADCS-ADL is a 23 item questionnaire completed by the caregiver assessing the basic and instrumental activities of daily living by the AD participant. Total score range from 0-78 with the higher score indicating increased independence.
Time frame: Up to Week 65
Neuropsychiatric Inventory-Q (NPI-Q) Scores over time
The NPI-Q is a questionnaire used to assess behavioral changes common in dementia patients. This questionnaire is completed by the caregiver. The questionnaire consists of 12 items with each item having a scoring range between 0-3. The higher score indicates a more severe neuropsychiatric symptomatology.
Time frame: Up to Week 52
Caregiver's Quality of life over time as assessed by the Caregiver Self-Assessment Questionnaire scores
The Caregiver Self-Assessment questionnaire is completed by the caregiver. It is an 18-item questionnaire answered with a "yes" or "no". Evidence of distress is indicated for having over 10 "yes" answers.
Time frame: Up to Week 52
Biomarker levels over time
Serum blood inflammatory and biomarker levels will be evaluated including Interleukin-6 (IL-6), Neurofilament light (NfL), Amyloid Beta 40 (Aβ40) and Amyloid Beta 42 (Aβ42) in pg/mL.
Time frame: Up to Week 65
Serum ApoE level over time
Serum blood Apolipoprotein E (ApoE) will be evaluated in mg/dL.
Time frame: Up to Week 65
Serum PRA level over time
Serum blood Plasma Renin Activity (PRA) will be evaluated in ng/mL per hour.
Time frame: Up to Week 65
Serum Tau protein level over time
Serum blood Tau protein level will be evaluated in ng/L.
Time frame: Up to Week 65
Cerebrospinal Fluid (CSF) Biomarker levels over time
CSF inflammatory and biomarker levels will be evaluated including Interleukin-6 (IL-6), Neurofilament light (NfL), Amyloid Beta 40 (Aβ40) and Amyloid Beta 42 (Aβ42) in pg/mL.
Time frame: Up to Week 52
CSF ApoE level over time
CSF Apolipoprotein E (ApoE) levels will be evaluated in mg/dL.
Time frame: Up to Week 52
CSF PRA level over time
CSF Plasma Renin Activity (PRA) levels will be evaluated in ng/mL per hour.
Time frame: Up to Week 52
CSF Tau protein level over time
CSF Tau protein levels will be evaluated in ng/L.
Time frame: Up to Week 52
Change in hippocampal volume
Change in hippocampal volume will be assessed via MRI Brain volumetric studies
Time frame: Baseline to Week 6, Baseline to Week 52