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EHT0202 in Alzheimer's disease: a 3-month, randomized, placebo-controlled, double-blind study
1CHU La Grave-Casselardit and INSERM U558, Toulouse, France.
Current Alzheimer Research
|January 13, 2011
Summary
EHT0202 (etazolate hydrochloride) demonstrated good safety and tolerability in mild to moderate Alzheimer's Disease patients. Further studies are needed to confirm its efficacy and long-term safety in a larger patient group.
Area of Science:
- Neuroscience
- Pharmacology
- Clinical Trials
Background:
- EHT0202 (etazolate hydrochloride) is a novel compound for Alzheimer's Disease (AD).
- It targets alpha-secretase activity, GABA-A receptors, and PDE-4.
- Potential disease-modifying and symptomatic treatment properties are being investigated.
Purpose of the Study:
- To assess the clinical safety and tolerability of EHT0202.
- To explore the potential clinical efficacy of EHT0202 as an adjunctive therapy.
- To evaluate EHT0202 in patients with mild to moderate Alzheimer's Disease.
Main Methods:
- A pilot, randomized, double-blind, placebo-controlled, multicentre Phase IIA study.
- 159 patients with mild to moderate AD received EHT0202 (40 or 80 mg bid) or placebo.
- Treatment was adjunctive to acetylcholinesterase inhibitors over 3 months.
Main Results:
- EHT0202 was found to be safe and generally well tolerated.
- Dose-dependent adverse events, including CNS-related events and early withdrawals, were observed.
- No significant differences in efficacy endpoints were noted between groups, except for ADCS-ADL scores.
Conclusions:
- Encouraging safety results support further development of EHT0202.
- Clinical efficacy and long-term tolerability require assessment in larger cohorts.
- EHT0202 shows promise for Alzheimer's Disease treatment.
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