Re: A Clinical Trial with Dr. Roberta Brinton

[Julie G]

I mentioned this clinical trial opportunity in another email, but wanted to highlight it in a separate thread. Dr. Brinton (and team) are currently enrolling participants for their Allopregnanolone Regenerative Therapeutic for MCI/AD Trial described below. Clinic visits to USC in Los Angeles are required:

https://clinicaltrials.gov/ct2/show/NCT ... one&rank=1

Inclusion Criteria:
* Men or postmenopausal women
* 55 years of age or older
* Diagnosis of MCI due to AD or mild AD
* MMSE > 20 at screen
* Capacity to provide informed consent
* Residing in the community with a caregiver able to accompany the patient to clinic visits
* No medical contraindications to participation
* Willingness to comply with study procedures
Exclusion Criteria:
* Use of benzodiazepines, sedative/hypnotics, anticonvulsants, antipsychotics, and other drugs that might interact with the GABA-A receptor complex
* Seizure disorder, history of stroke, focal brain lesion, traumatic brain injury, substance abuse, malignancy
* Clinically significant laboratory or ECG abnormality
* MRI indicative of any other significant abnormality, including but not limited to evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions
* Any condition that would contraindicate an MRI such as the presence of metallic objects in the eyes, skin, heart, or body

The paper below outlines the basis for the trial. I find it fascinating that Allo has been found to promote the transport and clearance of cholesterol from the brain which could have potential benefit to reduce beta amyloid generation. I’ve got full-text in PDF form. If you PM me your email, I’ll send you a copy.
Neurosteroids as regenerative agents in the brain: therapeutic implications
http://www.ncbi.nlm.nih.gov/pubmed/23438839

[Surfrank57]

Julie , Sandy meets all the
criteria except location. How often are the clinic visits I wonder? Make it a round robin. Go see Bredesen then Brinton.....two for one deal. Lol

Frank

[Julie G]

Hey Frank! I would call or email the contact info to learn more. FWIW, I think Allo shows great promise...but suspect that Sandy would be disqualified because of all of the Bredesen inspired confounders .

[SusanJ]

Just to follow up to this thread.

Results from a Pilot Clinical Trial of Allopregnanolone: A Regenerative Therapy for Alzheimer’s Disease

Roberta Diaz Brinton, PhD, from the University of Arizona, is conducting a phase 1b/2a pilot trial of allopregnanolone (allo), a neuro-steroid. In previous studies, she found that allo activates neural stem cell proliferation. Initial results from the pilot trial indicate that allo is safe and appears to prevent atrophy in the hippocampus compared to placebo, with patients responding to allo being overwhelmingly APOE4-positive. Surprisingly, Dr. Brinton found that the left and right sides of the hippocampus don’t react to the drug the same way, and male and female patients also responded differently. She plans to investigate these outcome further in future trials.

Presented at the 18th Annual Conference on Alzheimer's Drug Discovery.

Here's the press release from the conference.

https://www.alzdiscovery.org/news-room/ ... -amyloid-r

[Julie G]

Great to learn more about this target that appears to be even more important for our population. Thanks for sharing, Susan.

Results from a Pilot Clinical Trial of Allopregnanolone: A Regenerative Therapy for Alzheimer’s Disease: Roberta Diaz Brinton, PhD, from the University of Arizona, is conducting a phase 1b/2a pilot trial of allopregnanolone (allo), a neuro-steroid. In previous studies, she found that allo activates neural stem cell proliferation. Initial results from the pilot trial indicate that allo is safe and appears to prevent atrophy in the hippocampus compared to placebo, with patients responding to allo being overwhelmingly APOE4-positive. Surprisingly, Dr. Brinton found that the left and right sides of the hippocampus don’t react to the drug the same way, and male and female patients also responded differently. She plans to investigate these outcome further in future trials.