CMS-10583 IDEAS Post - PET form

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)
CLINICAL ASSESSMENT FORM (POST-PET FORM)
This form is used to record the revised diagnosis and actual management plan at the 3 months
post-PET clinical visit, now incorporating amyloid PET results.
If 90-day follow-up cannot be completed because the patient died, withdrew from care by the
dementia specialist, withdrew consent, or was lost to follow-up, the specific reasons must be
recorded on the post-PET CRF.
1. Please specify the reason if the 90-day follow up was not completed because
participant:
 Died
 Withdrew from care by dementia specialist
 Withdrew consent
 Was lost to follow up (after a minimum of three attempts to contact participant and/or
proxy as appropriate)
2.




Please specify the results of the amyloid PET scan (as you understand them):
Positive for cortical beta-amyloid
Negative for cortical beta-amyloid
Uninterpretable/technically inadequate study

3. Did the patient or family report any adverse effects due to learning amyloid status?
YES (If YES, please describe adverse event in comments)
NO
DIFFERENTIAL DIAGNOSIS
(Note: for any changes in diagnosis, the clinician is asked: “Is this change related to the
amyloid PET result [yes/no])?
•

4. Please enter the MOST likely etiologic cause of cognitive impairment (select one):
Neurodegenerative:
o Alzheimer’s disease (please specify below):
 AD, clinically typical (memory-predominant)
 AD, clinically atypical (non-amnestic)
 AD, mixed pathology (e.g. mixed vascular, Lewy body, etc.)
 AD, NOS
o Non-AD neurodegenerative (please specify below):
 Vascular cognitive impairment (includes: multi-infarct, subcortical,
intracerebral hemorrhage, other)
 Diffuse Lewy body disease
 Parkinson’s disease
 Frontotemporal dementia (includes behavioral and language-predominant
presentations, corticobasal syndrome and progressive supranuclear paly)
 Hippocampal sclerosis

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)

•

•
•

•

•
•

•

 Chronic traumatic encephalopathy (CTE)
 Other (allow free text):
Other CNS conditions (please specify below – forced to choose one):
 Hydrocephalus (idiopathic or secondary)
 Epilepsy
 Multiple sclerosis
 Brain mass
 Traumatic brain injury (static)
 Auto-immune encephalopathy (e.g. CNS lupus, cerebral vasculitis, limbic
encephalitis, paraneoplastic syndrome, etc.)
 Infectious encephalopathy (e.g. encephalitis or post-encephalitic encephalopathy,
HIV, neurospyphilis, Lyme disease, etc.)
 Prion disease
 Encephalopathy NOS
 Other (allow free text):
Cognitive changes due to normal aging (no pathological process suspected)
Primary psychiatric disease (please specify below – forced to choose one):
 Major depression
 Bipolar affective disorder
 Schizophrenia
 Other (allow free text):
Toxic-metabolic encephalopathy (please specify below – forced to choose one):
 Substance abuse (alcohol or recreational drugs)
 Polypharmacy or prescription drug side effects
 Primary systemic illness (e.g. hypo/hyperglycemia, CHF, COPD, kidney or liver
failure, hypothyroidism, etc.)
 Hypoxic-ischemic encephalopathy
 Nutritional deficiency (e.g. Vitamin B12, folate, thiamine)
 Other (allow free text):
Primary sleep disorder (e.g. insomnia, sleep apnea, etc.)
Other (allow free text):
5. Please enter at least one (and up to 3) additional items on your current differential
diagnosis:
Neurodegenerative:
o Alzheimer’s disease (please specify below):
 AD, clinically typical (memory-predominant)
 AD, clinically atypical (non-amnestic)
 AD, mixed pathology (e.g. mixed vascular, Lewy body, etc.)
 AD, NOS
o Non-AD neurodegenerative (please specify below):
 Vascular cognitive impairment (includes: multi-infarct, subcortical,
intracerebral hemorrhage, other)
 Diffuse Lewy body disease
 Parkinson’s disease

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)

•

•
•

•

•
•

 Frontotemporal dementia (includes behavioral and language-predominant
presentations, corticobasal syndrome and progressive supranuclear paly)
 Hippocampal sclerosis
 Chronic traumatic encephalopathy (CTE)
 Other (allow free text):
Other CNS conditions (please specify below – forced to choose one):
 Hydrocephalus (idiopathic or secondary)
 Epilepsy
 Multiple sclerosis
 Brain mass
 Traumatic brain injury (static)
 Auto-immune encephalopathy (e.g. CNS lupus, cerebral vasculitis, limbic
encephalitis, paraneoplastic syndrome, etc.)
 Infectious encephalopathy (e.g. encephalitis or post-encephalitic encephalopathy,
HIV, neurospyphilis, Lyme disease, etc.)
 Prion disease
 Encephalopathy NOS
 Other (allow free text):
Cognitive changes due to normal aging (no pathological process suspected)
Primary psychiatric disease (please specify below – forced to choose one):
 Major depression
 Bipolar affective disorder
 Schizophrenia
 Other (allow free text):
Toxic-metabolic encephalopathy (please specify below – forced to choose one):
 Substance abuse (alcohol or recreational drugs)
 Polypharmacy or prescription drug side effects
 Primary systemic illness (e.g. hypo/hyperglycemia, CHF, COPD, kidney or liver
failure, hypothyroidism, etc.)
 Hypoxic-ischemic encephalopathy
 Nutritional deficiency (e.g. Vitamin B12, folate, thiamine)
 Other (allow free text):
Primary sleep disorder (e.g. insomnia, sleep apnea, etc.)
Other (allow free text):
6. Please rate you level of confidence in the PRESENCE of AD pathology on a scale
of 0-10
0

1

2

3

4

5

6

7

8

9

10

MANAGEMENT PLAN
7. Please check all of the following pertaining to the actual management plan
(incorporating the result of amyloid PET):

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)

MANAGEMENT
ACTIONS
(See next table/questions for
drug management)
Watchful waiting only
(no new diagnostic tests,
drug adjustments,
counseling or referrals)
Counseling for safety,
planning & social support
Counseling about safety
precautions (home safety,
medication monitoring,
driving)
Counseling about
financial/medical decision
making, advanced
directives
Referral to community
patient/caregiver support
resources (e.g. social work,
Alzheimer’s Association,
Family caregiver Alliance,
etc.)
Other (specify) – free text
for pilot testing
Additional diagnostic
procedures
Neuropsychological
testing referral
Imaging (brain/head)
• CT/CTA with/without
contrast
• MRI/MRA
with/without contrast
• Brain FDG-PET
• DaTscan (Parkinson’s
disease)
• SPECT for regional
cerebral perfusion
• Other imaging (free text
for pilot testing)
Additional diagnostic
procedures, continued
Genetic tests
• ApoE genotyping

Implemented

Recommended
and pending

Recommended
but deferred
(by patient or
primary
provider)

Yes,
Change in
management
is related to
PET result

No,
Change in
management is
unrelated amyloid
PET result

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)
MANAGEMENT
ACTIONS
(See next table/questions for
drug management)
• Autosomal dominant
mutations for AD
• Autosomal dominant
mutations for other
conditions
EEG
Polysomnography
Other (specify -- free text
for pilot testing)
Referral to nonpharmacological
interventions
Other specialist (e.g.
psychiatrist, sleep
medicine)
Surgical intervention (e.g.
shunting for
hydrocephalus)
Substance abuse
treatment/support
programs
Physical, occupational or
speech therapy
rehabilitation
Cognitive rehabilitation
Clinical trial referral
AD therapeutic trial
includes amyloid (+) MCI
To non-AD therapeutic
trial (please specify)

Implemented

Recommended
and pending

Recommended
but deferred
(by patient or
primary
provider)

Yes,
Change in
management
is related to
PET result

No,
Change in
management is
unrelated amyloid
PET result

Other: _____________

Mark All Drugs: Therapies that have been be started, continued, adjusted, or stopped
(Incorporating Amyloid PET Result)

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)

DRUG DESCRIPTION
AD Symptomatic Drugs
Cholinesterase
inhibitors (donepezil,
rivastigmine,
galantamine)
Memantine
Non-AD drug
modification
Anti-depressants, mood
stabilizers
Anti-psychotics
Sedatives/sleep aids
Non-neuropsychiatric
drugs impacting
cognition
Anti-cholinergic drugs,
opiates, muscle
relaxants, etc.
Non-neurology/
psychiatric
pharmacologic
therapies*
Medical/vascular risk
factors
(e.g. anti-platelets, antihypertensives, diabetes
medications, lipid
lowering, etc.)

Other neurologic
condition
Parkinson’s Disease
Epilepsy
Targeted therapies
Immunosuppressant
(auto-immune/
inflammatory
encephalopathy)
Vitamin repletion
(nutritional deficiency)
Antimicrobials
(infectious
encephalopathy)

STARTED

CONTINUED

ADJUSTED

STOPPED

Yes,
Change in
management
is related to
PET result

No,
Change in
management
is unrelated
amyloid
PET result