UMIN-CTR Clinical Trial

Public title

Amyloid imaging study using positron emission tomography with [F-18]FACT for dementia

Acronym

Amyloid imaging study for dementia

Scientific Title

Amyloid imaging study using positron emission tomography with [F-18]FACT for dementia

Scientific Title:Acronym

Amyloid imaging study for dementia

Region

Japan

Condition

Dementia

Classification by specialty

Neurology	Psychiatry	Radiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate amyloid deposits in brain using positron emission tomography in Alzheimer's disease and mild cognitive impairment

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Comparison between patients and age- and gender-matched normal controls regarding follows:
- Amyloid deposits in brain measured by positron emission tomography
- Brain structure measured by magnetic resonance imaging
- Neuropsychological test

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

PET, MRI, Neuropsychological test

Interventions/Control_2

PET, MRI, Neuropsychological test

Interventions/Control_3

PET, MRI, Neuropsychological test

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

84

years-old

>=

Gender

Male and Female

Key inclusion criteria

Normal controls
- Subjects who have the ability to provide informed consent
- Memory Complaints
None
- Memory Function
Logical Memory II subscale (delayed Paragraph Recall) from the Wechsler Memory Scaled - Revised (the maximum score is 25):
a) more than or equal to 9 for 16 or more years of education
b) more than or equal to 5 for 10-15 years of education
c) more than or equal to 3 for 0-9 years of education
- MMSE
24-30
- CDR
0
Memory Box score must be 0
- General Cognition
Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
- Hachinski
Modified Hachinski score of less than or equal to 4

Mild cognitive impairment
- Memory Complaints
Memory complaint by subject or study partner that is verified by a study partner
- Memory Function
Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised:
a) less than or equal to 8 for 16 or more years of education
b) less than or equal to 4 for 10-15 years of education
c) less than or equal to 2 for 0-9 years of education
- MMSE
24-30
- CDR
0.5
Memory Box score must be at least 0.5
- General Cognition
General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit
- Hachinski
Modified Hachinski score of less than or equal to 4

Alzheimer's disease
- Memory Complaints
Memory complaint by subject or study partner that is verified by a study partner
- Memory Function
(Same as mild cognitive impairment)
- MMSE
12-26
- CDR
0.5-2
- General Cognition
NINCDS/ADRDA criteria for probable AD
- Hachinski
Modified Hachinski score of less than or equal to 4

Key exclusion criteria

Exclusion criteria for patients
- Other psychiatric disorders including drug dependence
- Brain organic diseases including cerebrovascular diseases, Parkinson's disease and other related disorders
- Serious medical illness
- Subjects who are judged as not suitable for participation in this study

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Ito, M.D., Ph.D.

Organization

National Institute of Radiological Sciences

Division name

Molecular Imaging Center

Zip code

Address

4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

National Institute of Radiological Sciences

Division name

Molecular Imaging Center

Zip code

Address

TEL

Homepage URL

Email

Institute

National Institute of Radiological Sciences

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2008

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2008

Year

11

Month

01

Day

Last follow-up date

2011

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

10

Month

09

Day

Last modified on

2012

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001733