Trial Outcomes & Findings for Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease (NCT NCT02222181)

Results Overview

MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

six months

Results posted on

2016-05-06

Participant Flow

Experimental, longitudinal and non-randomized study, carried out at Centro de Referência do Idoso de Araraquara (CRIA), from 2014 april to 2015 april, with patients in treatment for Alzheimer's disease.

Patients were excluded when in advanced or terminal stage of the disease, lived in nursing homes and when it was not possible to contact the patient.

Participant milestones

Participant milestones
Measure	Pharmacotherapy Follow-up All the patients received pharmacotherapy workup at baseline and after the intervention.
Overall Study STARTED	163
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	108

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=55 Participants patients in treatment for Alzheimer's disease.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	46 Participants n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: six months

MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)

Outcome measures

Outcome measures
Measure	Pharmacotherapy Follow-up n=55 Participants All the patients received pharmacotherapy workup at baseline and after the intervention.
Mini-mental State Examination (MMEE) Before	12 score Standard Deviation 7.3
Mini-mental State Examination (MMEE) After	12 score Standard Deviation 7.8

PRIMARY outcome

Timeframe: six months

CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage)

Outcome measures

Outcome measures
Measure	Pharmacotherapy Follow-up n=55 Participants All the patients received pharmacotherapy workup at baseline and after the intervention.
Clinical Dementia Rating (CDR) Before	1.6 score Standard Deviation 0.08
Clinical Dementia Rating (CDR) After	1.7 score Standard Deviation 0.08

SECONDARY outcome

Timeframe: weekly

Systolic pressure \<140 mmHg

Outcome measures

Outcome measures
Measure	Pharmacotherapy Follow-up n=55 Participants All the patients received pharmacotherapy workup at baseline and after the intervention.
Systolic Blood Pressure Before	136.6 mmHg Standard Deviation 22.3
Systolic Blood Pressure After	126.7 mmHg Standard Deviation 18.5

SECONDARY outcome

Timeframe: Total Cholesterol

Total Cholesterol \<200 mg/dL

Outcome measures

Outcome measures
Measure	Pharmacotherapy Follow-up n=55 Participants All the patients received pharmacotherapy workup at baseline and after the intervention.
Total Cholesterol After	187.6 mg/dL Standard Deviation 39.5
Total Cholesterol Before	202.2 mg/dL Standard Deviation 41.6

SECONDARY outcome

Timeframe: three months

Normal level: 150mg/dL

Outcome measures

Outcome measures
Measure	Pharmacotherapy Follow-up n=55 Participants All the patients received pharmacotherapy workup at baseline and after the intervention.
Triglycerides Before	154.1 mg/dL Standard Deviation 63.2
Triglycerides After	137.8 mg/dL Standard Deviation 48.7

SECONDARY outcome

Timeframe: two months

Normal levels: 70-99mg/dL; diabetic: \>121mg/dL.

Outcome measures

Outcome measures
Measure	Pharmacotherapy Follow-up n=55 Participants All the patients received pharmacotherapy workup at baseline and after the intervention.
Glycemia Before	121.9 mg/dL Standard Deviation 57.3
Glycemia After	93.9 mg/dL Standard Deviation 15.3

SECONDARY outcome

Timeframe: weekly

Diastolic pressure \<90 mmHg

Outcome measures

Outcome measures
Measure	Pharmacotherapy Follow-up n=55 Participants All the patients received pharmacotherapy workup at baseline and after the intervention.
Diastolic Blood Pressure Before	75.49 mmHg Standard Deviation 12
Diastolic Blood Pressure After	73.03 mmHg Standard Deviation 9.8

Adverse Events

Treatment

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

Fernanda Mariana de Oliveira

Unesp

Phone: +551636640217

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place