Mitochondria- and Oxidative Stress-Targeting Substances in Cognitive Decline-Related Disorders: From Molecular Mechanisms to Clinical Evidence

Table 3

Ongoing clinical trial on the effects of allopregnanolone in MCI and mild AD.

Study design	Allopregnanolone dose/preparation	Duration	Subjects	Purpose	Main results	References
R, DB, parallel assignment; Phase 1	Allopregnanolone 2, 4, or 6 mg intravenous injection once per week or placebo intravenous injection once per week	12 weeks	(8) For each dose group, 55 years and older, both genders; MCI or mild AD; (6) Randomized to AP; (2) Randomized to placebo	Determine the maximally tolerated dose, safety and tolerability, pharmacokinetic profile, and effects on cognitive function	Not available	NCT02221622 [133]

The number of patients involved in the trials is indicated in parentheses.