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Planned Clinical Studies

CogWellin™ is now actively working with both Pharmadiretions and Corealis Pharma to complete formulation of high-quality, GMP-grade once-daily salsalate for human testing as early as February 2017.

CogWellin™ targets the right patients at the right time.

Since the drug salsalate has been prescribed by physicians in the US since 1938 with 78 years of experience, it is highly unlikely the FDA will require testing CogWellin™ in healthy volunteers or in animal studies.

If the FDA has no objections to starting CogWellin™ in Alzheimer's disease patients without it being tested in healthy volunteers, this study will be done as a Proof of Concept (POC) program in such patients. It is hoped that CogWellin™ will result in a reduction in the level of CSF Ac-Tau.

Whether or not CogWellin™ can lower CSF Ac-Tau, three ambitious phase II/III studies will be done hopefully leading to FDA approval of the first Alzheimer's disease modifying and prevention drug.

All three studies below have had their protocols completely written, reviewed by experts in the field, and have had many patients prescreened for rapid enrolllment.

Three Ambitious Studies

ASAP

Alzheimer's Symptoms Are Preventable.
A study in those asymptomatic individuals ages 45 and over who have a family history of Alzheimer's disease with ApoE4 +/- presence of Ac-Tau in their cerebrospinal fluid.

ASAT

Alzheimer's Symptoms Are Treatable.
A study in those asymptomatic individuals ages 45 and over who have mild cognitive impairment (MCI) due to Alzheimer's disease with positive ApoE4 +/- Ac-Tau in their cerebrospinal fluid.

ADIT

Alzheimer's Dementia Is Treatable.
A study in those individuals ages 45 and over who have mild to moderate dementia due to Alzheimer's disease and ApoE4 positive +/- Ac-Tau in their cerebrospinal fluid.