The exploratory measures included the P300 electroencephalogram, MMSE score, the Computerized Cogstate Alzheimer's Battery, and the ADCS-ADL
. The Hamilton Depression (HAM-D) Scale was also employed as a neuropsychiatric symptom measure.
On the ADCS-ADL
, patients taking 75 mg twice a day scored 6.5 points higher than controls, indicating better function, and those taking 125 mg twice a day scored 6.9 points higher.
Functional decline in the alpha-tocopherol group, as evidenced by ADCS-ADL
scores, was delayed by 10.6 months in the first year, 8.7 months in the second, 9.3 months in the third, and 1.8 months in the fourth year.
Data from 561 participants were analyzed (52 were excluded because of lack of follow-up data) and found that ADCS-ADL
inventory scores declined by 3.15 units in the alpha tocopherol group compared with the placebo group.
There were no real differences for caregiver test measurements on participant function as measured by the ADCS-ADL
scale, but caregiver-reported participant quality of life as measured by the QoL-AD improved 2.2 points in the intervention group, compared with 0 points in the usual care group, for an effect size of 0.33.
On the ADCS-ADL
, patients taking 75 mg twice daily scored 6.5 points higher than did the placebo group, indicating better function, and those taking 125 mg twice daily scored 6.9 points higher than did the placebo group.
Memantine exerted "no significant effects" whether patients with mild AD were assessed using the Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-cog), the Clinician's Interview-Based Impression of Change Plus Caregiver's Input (CIBIC-plus), the Alzheimer Disease Cooperative Study-Activities of Daily Living (ADCS-ADL
) scale, or the Neuropsychiatric Inventory (NPI).
Primary and secondary endpoints will assess safety and both cognitive and functional efficacy, measured through ADAS-Cog, ADCS-ADL
The primary efficacy outcomes of the study are the change from baseline in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score, as well as the change from baseline in the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL
) score, following 78 weeks of treatment.
Secondary endpoints included the change from baseline on a 13-item version of the ADAS-Cog, the Mini Mental State Examination, the Clinician's Interview-Based Impression of Change, the Neuropsychiatric Inventory, and the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL
The companies said that Dimebon did not achieve statistically significant results for either of the two co-primary endpoints, the Alzheimer's Disease Assessment Scale, which is the cognitive subscale (ADAS-cog) which measures cognitive ability, or the Alzheimer's Disease Cooperative Study, the Activities of Daily Living (ADCS-ADL
), which measures self care and daily function.