No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 – 90
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
8 (estimated)
Sponsor
Bernard (Barry) Baumel · Other
Who this trial is looking for
This trial is looking for adults with moderate to severe Alzheimer's disease who have behavioral problems. Participants will receive one infusion of stem cells along with their current medication for behavior control.
Are You a Good Fit for This Trial?
Must be takingAntipsychotic medication
You may be able to join if
I am between 55 and 90 years old.
I have been diagnosed with probable Alzheimer's disease.
I have had brain imaging that shows signs of Alzheimer's disease.
I have behavioral symptoms like agitation or hallucinations.
My behavioral symptoms started at least 4 weeks before screening.
I have been taking antipsychotic medication for at least 4 weeks.
I have a family member or friend who can answer questions about me.
You may not be able to join if
I have dementia other than Alzheimer's disease.
I have severe depression.
I have a recent history of substance abuse.
I have a bleeding disorder or certain viral infections.
I have had cancer in the past 3 years, except for some treated skin cancers.
I have uncontrolled medical conditions like hypertension or diabetes.
I have received experimental treatments for Alzheimer's disease recently.
I am premenopausal.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help control behavioral problems in people with a diagnosis of moderate to severe Alzheimer's disease.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Adults 55-90 years at the time of signing consent
* A diagnosis of probable Alzheimer disease (AD), defined by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* …
Inclusion Criteria:
* Adults 55-90 years at the time of signing consent
* A diagnosis of probable Alzheimer disease (AD), defined by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* Previous computed tomography or magnetic resonance imaging scan of the brain with findings consistent with a diagnosis of Alzheimer disease
* A diagnosis of behavioral symptoms that include any of the following: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and nighttime behavior disorders and appetite and eating disorders
* Onset of behavioral symptoms at least 4 weeks prior to screening.
* Treatment with antipsychotic medication for at least 4 weeks prior to the hMSC infusion.
* Patients unable to consent should have a Legally Authorized Representative or Proxy to provide consent on their behalf.
* Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and able to answer questions about the participant's behavior.
Exclusion Criteria:
* Dementia other than AD
* Patient with severe depression. Patient with controlled depression is allowed to participate.
* Recent history of substance abuse
* History of bleeding disorders, HIV, Hepatitis C Virus or Hepatitis B Virus
* Recent history (within 3 years) of malignancies, except for treated basal cell, squamous carcinoma or melanoma in situ, prostate in situ, cervical carcinoma in situ.
* Uncontrolled medical conditions (hypertension, diabetes, unstable angina or Myocardial Infarction within 1 year prior to screening)
* History of bleeding disorder
* Currently receiving (or received within four weeks of screening) experimental agents for the treatment of Alzheimer's Disease or enrolled in clinical trials in the prior 3 months.
* Be a transplant recipient or in any other active medical condition than in the opinion of the investigator may compromise the safety or compliance of the patient or preclude successful completion of the study
* Be premenopausal
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