Trial Outcomes & Findings for Good Rate of Clinical Response to Cholinesterase Inhibitors in Alzheimer's Disease After Three Months of Treatment (NCT NCT02007291)

Results Overview

Patients presented mild or moderate dementia according to the Clinical Dementia Rating (CDR). None of the individuals had been treated with Cholinesterase inhibitors (ChEI) or memantine before study entry. Donepezil, galantamine or rivastigmine were prescribed to the patients according to the clinicians' preferences. All participants were evaluated by one board certified geriatrician (LFJRM) at baseline and after 3 months of treatment, as part of an ongoing 12-month responder analysis study of ChEI in Alzheimer's Disease. The main domain examined and the evaluation tools was cognition and Mini-Mental State Examination- MMSE, respectively. MMSE scores range from 0 to 30, while the greater value is associated with a better cognition state. An increase of 2 or more points in MMSE was considered as response.

Recruitment status

COMPLETED

Target enrollment

71 participants

Primary outcome timeframe

three months

Results posted on

2018-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	CDR1 Patients Taking Cholinesterase Inhibitors The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.	CDR2 Patients Taking Cholinesterase Inhibitors The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.
Overall Study STARTED	48	23
Overall Study COMPLETED	48	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Good Rate of Clinical Response to Cholinesterase Inhibitors in Alzheimer's Disease After Three Months of Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Taking Cholinesterase Inhibitors n=71 Participants The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.
Age, Customized ≤ 69 years old	12 Participants n=5 Participants
Age, Customized 70-79 years old	36 Participants n=5 Participants
Age, Customized ≥ 80 years old	23 Participants n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Region of Enrollment Brazil	71 Participants n=5 Participants

PRIMARY outcome

Timeframe: three months

Patients presented mild or moderate dementia according to the Clinical Dementia Rating (CDR). None of the individuals had been treated with Cholinesterase inhibitors (ChEI) or memantine before study entry. Donepezil, galantamine or rivastigmine were prescribed to the patients according to the clinicians' preferences. All participants were evaluated by one board certified geriatrician (LFJRM) at baseline and after 3 months of treatment, as part of an ongoing 12-month responder analysis study of ChEI in Alzheimer's Disease. The main domain examined and the evaluation tools was cognition and Mini-Mental State Examination- MMSE, respectively. MMSE scores range from 0 to 30, while the greater value is associated with a better cognition state. An increase of 2 or more points in MMSE was considered as response.

Outcome measures

Outcome measures
Measure	CDR 1 Patients Taking Cholinesterase Inhibitors n=43 Participants The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.	CDR 2 Patients Taking Cholinesterase Inhibitors n=28 Participants The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.
Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease MMSE- baseline	19 units on a scale Standard Deviation 4.3	11.3 units on a scale Standard Deviation 2.4
Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease MMSE - 3 months	18.9 units on a scale Standard Deviation 4.5	11.5 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: three months

Patients presented mild or moderate dementia according to the Clinical Dementia Rating (CDR). None of the individuals had been treated with Cholinesterase inhibitors (ChEI) or memantine before study entry. Donepezil, galantamine or rivastigmine were prescribed to the patients according to the clinicians' preferences. All participants were evaluated by one board certified geriatrician (LFJRM) at baseline and after 3 months of treatment, as part of an ongoing 12-month responder analysis study of ChEI in AD. The secondary domain examined was independence for daily activities and the evaluation tools used was the brazilian version of the Pfeffer Functional Activities Questionnaire (PFAQ). PFAQ scale range from 0 to 30 points and the greater value is associated with a greater dependence in daily activities.

Outcome measures

Outcome measures
Measure	CDR 1 Patients Taking Cholinesterase Inhibitors n=43 Participants The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.	CDR 2 Patients Taking Cholinesterase Inhibitors n=28 Participants The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription.
Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease PFAQ - baseline	14.9 units on a scale Standard Deviation 8.8	26.9 units on a scale Standard Deviation 4.1
Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease PFAQ - 3 months	16.2 units on a scale Standard Deviation 8.8	27.1 units on a scale Standard Deviation 3.5

Adverse Events

CDR1 Patients Taking Cholinesterase Inhibitors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CDR2 Patients Taking Cholinesterase Inhibitors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Luís Felipe José Ravic de Miranda

Federal University of Minas Gerais

Phone: 55-31-3225-2337

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place