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Evaluating the effect of Donepezil on Cerebral Blood Flow Velocity in Alzheimer's disease

Protocol summary

Summary
This clinical trial was carried out in department of Neurology in Alzahra Hospital (Isfahan University of Medical Sciences) from March 5, 2008 to July 28, 2009 and was performed on AD patients in two groups of case and control, each consisting of 11 patients. The inclusion criterion was age between 50 and 80 years, and the exclusion criteria included history of stroke, nontreated hypertension, diabetes mellitus, smoking during the past 10 years, hypercholesterolemia and taking AchEI drugs one month prior to the study. Methods: Out of 30 patients, 22 patients completed the study and included for the study.This clinical trial was performed on AD patients in two groups of case and control, each consisting of 11 patients. The case group who received Donepezil medication was examined by TCD before (baseline), after four weeks of oral treatment with 5mg per day Donepezil and a further four weeks of 10mg per day Donepezil, administered orally. The control group were AD patients who did not receive any medications effective on AD and were examined by TCD only once. Peak systolic (PSV), end-diastolic (EDV) and mean flow (MFV) velocities of posterior cerebral artery (PCA) and middle cerebral artery (MCA) were assessed by TCD. Also, mini-mental state examination (MMSE) was carried out.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812183518N1
Registration date: 2010-05-20, 1389/02/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-05-20, 1389/02/30
Registrant information
Name
Mehdi Shishegar
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 4444
Email address
shishegar@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Isfahan, Iran.
Expected recruitment start date
2008-04-03, 1387/01/15
Expected recruitment end date
2009-07-21, 1388/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Donepezil on Cerebral Blood Flow Velocity in Alzheimer's disease
Public title
Evaluating the effect of Donepezil on Cerebral Blood Flow Velocity in Alzheimer's disease
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria : age between 50 and 80 years, and the exclusion criteria : history of stroke, nontreated hypertension, diabetes mellitus, smoking during the past 10 years, hypercholesterolemia and taking AchEI drugs one month prior to the study.
Age
From 50 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In this study, 19 patients with AD were initially allocated to the case group. Out of the 19 patients, five did not continue participating in the study after four weeks of treatment with Donepezil, one patient in the second round of follow up did not cooperate to perform TCD and two were excluded due to discontinuation of the drug because of agitation side effect and finally 11 patients remained in the case group. Also, 11 patients with AD were allocated to the control group. The case group comprised patients who were treated with Donepezil; and TCD was performed every four weeks. The control group consisted of Alzheimer's disease patients who did not use any medication; and inclusion and exclusion criteria similar to those for the case group were applied to this group, and TCD was performed only once for them.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences, Isfahan, Iran
Street address
faculty of medicine,Isfahan University of Medical Sciences, Isfahan.
City
Isfahan
Postal code
صندوق پستي 817467573
Approval date
empty
Ethics committee reference number
388239

Health conditions studied

1

Description of health condition studied
Alzheimer's disease
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease

2

Description of health condition studied
Alzheimer's disease
ICD-10 code
F00
ICD-10 code description
Dementia in Alzheimer's disease

Primary outcomes

1

Description
Mini Mental State Examination
Timepoint
before, 1 month and 2 months after intervention
Method of measurement
with checklist

2

Description
Peak systolic flow velocity
Timepoint
before, 1 month and 2 months after intervention
Method of measurement
Transcranial Doppler sonography

3

Description
Peak diastolic flow velocity
Timepoint
before, 1 month and 2 months after intervention
Method of measurement
Transcranial Doppler sonography

4

Description
mean flow velocity
Timepoint
before, 1 month and 2 months after intervention
Method of measurement
Transcranial Doppler sonography

Secondary outcomes

empty

Intervention groups

1

Description
In control group no drug was used and only one time carry out TCD
Category
N/A

2

Description
Donepazil(oral) tab with dose of 5mg/d for 1 month and then 5mg/d every 12 hours for another 1 month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mehdi Shishegar MD
Street address
Department of Neurology, Isfahan Neuroscience Research Center, Alzahra hospital, Sofeh St, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Mojtaba Akbari
Street address
faculty of medicine,Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Grant name
از معاونت پژوهشی دانشگاه علوم پزشکی اصفهان
Grant code / Reference number
388239
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Isfahan, Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Mehdi Shishegar MD
Position
Resident of Neurology
Other areas of specialty/work
Street address
Department of Neurology, Isfahan Neuroscience Research Center, Alzahra hospital, Sofeh St.
City
Isfahan
Postal code
8174675731
Phone
+98 31 1668 4444
Fax
+98 31 1669 2174
Email
shishegar@resident.mui.ac.ir
Web page address
www.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Mehdi Shishegar MD
Position
Resident of Neurology
Other areas of specialty/work
Street address
Department of Neurology, Isfahan Neuroscience Research Center, Alzahra hospital, Sofeh St.
City
Isfahan
Postal code
8174675731
Phone
+98 31 1668 4444
Fax
+98 31 1669 2174
Email
shishegar@resident.mui.ac.ir
Web page address
www.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran.
Full name of responsible person
Mehdi Shishegar MD
Position
Resident of Neurology
Other areas of specialty/work
Street address
Department of Neurology, Isfahan Neuroscience Research Center, Alzahra hospital, Sofeh St.
City
Isfahan
Postal code
8174675731
Phone
+98 31 1668 4444
Fax
+98 31 1669 2174
Email
shishegar@resident.mui.ac.ir
Web page address
www.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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