Alzheimer Alzheimer's Disease
Conditions
Interventions
Three NurOwn® (MSC-NTF cells) treatments will be given by intrathecal
administration every two months. Study drug will be supplied in one 5 mL
syringe containing 4 mL of NurOwn® (MSC-NTF cells) susp
Sponsors
Worldwide Clinical Trials Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Males and females, ages 50 to 75 years old, inclusive, at the Screening Visit (Visit 1). 2. Clinical diagnosis of prodromal to mild AD at least 6 months prior to enrollment, based on the International Working Group (IWG-2) diagnostic criteria or the National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria. 3. Mini Mental State Examination (MMSE) of 20-30, inclusive, and Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0 4. Demonstrated abnormal memory function 5. CSF profile consistent with AD: Amyloid Beta 42 (Aβ42) concentration of <1000 pg/ml AND P-tau >19 pg/ml or ratio of p-tau/Abeta > 0.024 (Elecsys assay) 6. If currently treated with Cholinesterase Inhibitors (AChEI) (donepezil, galantamine, or rivastigmine) or Memantine the dose should be stable for at least 12 weeks prior to Screening (Visit 1). 7. Must have a caregiver that is willing to participate in the study and is able to provide accurate information on the participant's cognitive and functional ability. 8. Must consent to apolipoprotein E (ApoE) genotyping or willing to provide previous test results. 9. If sexually active and of childbearing potential, both females and males must agree to use an effective birth control method during the study and for at least 3 months following the last transplantation, such as: abstinence, intrauterine device (IUD), oral contraception, barrier and spermicide or hormonal implant.
Exclusion criteria
Exclusion criteria: 1. Prior stem cell therapy of any kind. 2. Active participation in any other interventional study or use of unapproved AD investigational therapy within 60 days prior to the Screening Visit (Visit 1), unless proven to have been on placebo. 3. Inability to lie flat for the duration of intrathecal cell administration and/or bone marrow aspiration, or inability to tolerate study procedures for any other reason. 4. History of clinically significant autoimmune disease (excluding thyroid disease) that may confound study results, myelodysplastic or myeloproliferative disorder, leukemia or lymphoma, whole body irradiation, hip fracture, or severe scoliosis. 5. Any poorly controlled clinically significant medical condition other than Alzheimer*s disease (e.g., within six months of Screening Visit (Visit 1), such as myocardial infarction, angina pectoris, congestive heart failure, or hypertension (repeated blood pressure >180 mmHg systolic or 100 mmHg diastolic) as well as clinically significant coagulopathy, treatment with anticoagulants that, in the opinion of the investigator, would compromise the safety of participants. 6. Any history of malignancy (e.g., myeloproliferative disorder, leukemia or lymphoma) within the previous 5 years, except for non-melanoma localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of Screening Visit (Visit 1)). 7. Any history of acquired or inherited immune deficiency syndrome. 8. Platelet count, INR, PT or PTT not within the normal range (local protocol) or other risk for increased or uncontrolled bleeding (safety for lumbar puncture and bone marrow). 9. Presence of contraindication to lumbar puncture as judged by local PI, e.g. need for anticoagulant or antiplatelet medications other than aspirin at a dose of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To evaluate AD-specific, neuroinflammatory, neurotrophic and neurodegenerative biomarkers and safety of 3 intrathecal (IT) administrations of NurOwn® (MSC-NTF cells) given at two monthly intervals to participants with prodromal to mild Alzheimer*s Disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate cognitive and clinical efficacy outcome measures, including CDR-SB, FCSRT, NTB and D-KEFS subtests, A-IADL-Q-SV, as well as the MMSE. | — |
Countries
Netherlands
Outcome results
None listed