Coke oven gas (COG)

- process gases (e.g. coke oven gas(COG) and blast furnace gas(BFG)),

- process gases (coke oven gas/COG, blast furnace gas/BFG and basis oxygen furnace gas/BOFG),

During carbonisation in the coke chamber of the coke oven, coal is converted under the exclusion of air to coke and crude coke oven gas (crude COG).

Generally these installations also produce process gases of different compositions, e.g. coke oven gas/COG, blast furnace gas/BFG, basic oxygen furnace gas/BOFG).

ADAS-Cog Placebo

ITT-LOCF population ADAS-Cog

ADAS-Cog: improvement of at least 4 points

The Applicant has committed to provide data from an on-going COG study AALL0434.

At least 4 points improvement on ADAS- Cog with no worsening on CIBIC-Plus and PDS

Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate.

ITT-LOCF population At least 4 points improvement on ADAS-Cog with no worsening on ADCS- CGIC and ADCS-ADL

Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).

The secondary definition of response required a 4-point or greater improvement on the ADAS-Cog, no worsening on the CIBIC-Plus, and no worsening on the PDS.

Clinically relevant improvement in these studies was defined a priori as at least 4-point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10 % improvement on the PDS.

Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).

Efficacy has been established by the use of two independent scales which were assessed at regular intervals during a 6-month treatment period as shown in Table 5 below: the ADAS-Cog, a measure of cognition, and the global measure ADCS-CGIC (Alzheimer’ s Disease Cooperative Study- Clinician’ s Global Impression of Change).

Efficacy has been established by the use of two independent scales which were assessed at regular intervals during a 6-month treatment period as shown in Table 5 below: the ADAS-Cog, a measure of cognition, and the global measure ADCS-CGIC (Alzheimer’ s Disease Cooperative Study- Clinician’ s Global Impression of Change). Table 5

These include the ADAS-Cog (a performance based measure of cognition), the CIBIC-Plus (a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities relating to finances, etc.).

These include the ADAS-Cog (a performance-based measure of cognition) and the ADCS-CGIC (a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the ADCS-ADL (a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities related to finances).