University of Miami
Miami, Florida, 33136, United States
NCT Number: NCT04040348
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.
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Notify Me50 year–85 year
All sexes
Interventional
Phase 1
Miami, Florida, 33136, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All subjects enrolled in this trial must:
Exclusion criteria
All subjects enrolled must not have:
Umbilical cord-derived, allogeneic hMSC administered intravenously at a dose of approximately 100 million cells per infusion.
Time frame: One month post-infusion
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:
Time frame: Up to Week 65
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
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
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
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
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 52
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
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 65
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 blood Apolipoprotein E (ApoE) will be evaluated in mg/dL.
Time frame: Up to Week 65
Serum blood Plasma Renin Activity (PRA) will be evaluated in ng/mL per hour.
Time frame: Up to Week 65
Serum blood Tau protein level will be evaluated in ng/L.
Time frame: Up to Week 52
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 Apolipoprotein E (ApoE) levels will be evaluated in mg/dL.
Time frame: Up to Week 52
CSF Plasma Renin Activity (PRA) levels will be evaluated in ng/mL per hour.
Time frame: Up to Week 52
CSF Tau protein levels will be evaluated in ng/L.
Time frame: Baseline to Week 6, Baseline to Week 52
Change in hippocampal volume will be assessed via MRI Brain volumetric studies
Bernard (Barry) Baumel
Other
A Phase I, Prospective, Open-label Trial to Evaluate the Safety, Tolerability and Exploratory Outcomes of Multiple Allogeneic Human Mesenchymal Stem Cells (HMSC) Infusions in Patients With Mild to Moderate Alzheimer's Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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