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Psych 403 > W12 > Flashcards

W12 Flashcards

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1
Q

what was the most voted answer for what do you think the best reason to participate in research is?

A

may benefit from the experimental treatment

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2
Q

what are therapeutic misconceptions?

A
  • majority of research is non-therapeutic,, despite the intention
  • no difference in long-term outcomes between AD patients who participate in clinical trials and those who don’t
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3
Q

what is the most voted answer for what do you think the biggest obstacle is to participating in research?

A

possibility of side effects

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4
Q

what is the most voted answer for “if you were Pat, would you prefer to learn about risks and the benefits of the study by”:

A

discussing with research coordinator

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5
Q

what type of info from placemat survey was the highest and lowest?

A

blood
family history

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6
Q

has trust changed between academia and industry?

A

yes now more overlap
- building therapeutic treatment plan

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7
Q

what is the most voted answer for “if you were Pat, would you want to know the results from the tests for research purposes?

A

yes from all the tests

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8
Q

what is the most voted answer for which of the issues Pat faced do you think is the most important?

A

finding ways to maximize research participation

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9
Q

what are the benefits of engagement?

A
  • better patient experience
  • better health outcomes
  • higher quality research
  • lower costs
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10
Q

what are the challenges of dementia?

A
  • verbal communication impairment
  • memory loss
  • decision-making capacity
  • emotional dispostion
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11
Q

what are the strategies for dementia?

A
  • personalized methodology
  • greater flexibility
  • preliminary meetings with person and carer
  • research training
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12
Q

what are the benefits to digital biomakrers?

A
  • track progression and trends
  • feel empowered
  • monitor symptoms
  • optimize treatments
  • analyze precise data sets about disease and response
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13
Q

what are the 2 things for biomarkers?

A

to capture and disclosure

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14
Q

what is active data collection?

A

user prompted to perform an assessment or enter a value

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15
Q

what is passive data collection?

A

values are acquired unobtrusively and sometimes without knowledge of user

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16
Q

what are the 5 components of data collection?

A

consent - esp important for passive collection, ask for consent in intervals
privacy
conflict of interest - 3rd party use of data
complementarity - active data collection, don’t want to jeopardize data
emotional impact

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17
Q

attributes towards digital biomarkers

A
  • growing acceptance
    +: increased efficiency and accuracy, mitigation of human error, more frequent data capture
  • : neg emotions (self-blame, anxiety)
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18
Q

what are the considerations for research design?

A
  • study group allocation and exclusion (interpretation)
  • behavioral changes and influence on study findings (emotional impact)
  • impact on research experience for participants (decision-making)
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19
Q

proactively addressing ethics and literacy through engagement

A

advisory
consultation
co-creation
eval
research

20
Q

what is the clinical trial phase pipeline?

A

P1: test new treat in healthy, determine effects, 20-80, clinical researcher, months (side effects)

P2: test new treatment on patients, eval safety and efficacy, 100-300, clinical researcher, 2 yrs

P3: test new treatment, eval efficacy, safety, effectiveness, 300+, researcher and physician, several years

FDA review and approval

21
Q

trial vs phase

A

number of trials can be performed in phase

22
Q

what is the duration of a trial

A

length of time for recruitment and treatment period
- recruitment difficult

23
Q

what is the duration of phase

A

trials + analysis + decision making

24
Q

is progression sequential?

A

no

25
Q

what are repurposed drugs?

A

drugs tested for other diseases or conditions tested in alternate order or skip phases

26
Q

what is a mechanism associated with AD therapies?

A

disease-modifying: patient experience clinical response and there is impact on disease process
- small molecule
- immunotherapies

27
Q

what is small molecule?

A

AB production, aggregation, clearance
tau phosphorylation and assembly
BACE inhibition
neuroprotective strategies

28
Q

what is immunotherapies?

A

active: stimulation immune sys to target AB and tau-related pathology
passive: does not invoke immune sys, required reg injection of antibodies

29
Q

what is involved in symptomatic therapies?

A
  • cognitive enhancing agents
  • behavior agents
30
Q

what are cognitive-enhancing agents?

A

patients experiences cog improvement above baseline, but compound does not alter underlying disease process

31
Q

what are behavior agents?

A

patients experiences behavioral improvemeent above baseline but compound does not alter underlying disease process
- depression, agitation, sleep disorders, aggression

32
Q

what are the 8 currently approved treatments?

A

tacrine
donepezil
ricastigmine
galantamine
memantine - symptomatic releif
aducanunab
lecanemab

33
Q

what is aducanumab?

A

anti-amyloid reducing drug
- 1st clinical trial drug that treats the neuropathology of ad
- discontinued now

34
Q

why was aducanumab discontinued?

A

biogen: reprioritizes resources
side effect: amyloid related imaging abnormalities
- brain swelling and microhemorrages
- confusion, dizziness, delirium, vision abnormality, altered mental status

35
Q

what does Lecanemab do to AD?

A

stick to amyloid protein
antibody attracts immune cells to break down protein
less protein around neuron

36
Q

what does Donanemab do?

A

attacks the amyloid plaques later on in stages
- removes amyloid
- slows the progression
- modifies disease

37
Q

what is the most common form of candidate treatments in pipeline?

A

disease-modifying

38
Q

what is phase 1 for disease-modifying?

A

52% biologics
29% small molecule
- mechanisms: amyloid, inflammation, transmitter receptors, tau, metabolism and bioenergetics
- 23% of P1 agents repurposed treatments approved for use in another indication

39
Q

how are stem cells used for AD?

A

8 trials developing
- allogenic human mesenchymal stem cells : P2
- amniotic and umbilical cord tissue : P1
- autologous adipose tissue derived mesenchymal stem cells : P2
- lomocel-B mesenchymal stem cells derived from bone marrow : P2

40
Q

what is the amyloid cascade hypothesis?

A

amyloid B causes synaptic and neuron function dysregulation
creates intercellular conditions for the formation of tau pathology
neuronal loss and compromised nt fxn

41
Q

what are add-on trials?

A

new drug compared with placebo in patients who already receiving treatment with background therapy

42
Q

what are combination trials?

A
  • two drugs tested 2x2
  • alone, combo, compared to placebo
  • tests 2 targets
  • tests two therapies on one target
  • test delivery modes
  • sequential combo
  • multifunctional agent targeting 1 or more activity or target
43
Q

placebo-controlled 2x2 design

A

a + P
b + P
a + b
P +P

add-on:
standard of care + b
standard + P
no standard + B
no standard + P

  • well controlled
  • compare effects of each drug and synergistic effects of both
44
Q

3-arm design

A

a
b
a + b
+ : no patient untreated, small trial with easier recruitment
- : hard to discriminate effects, less appropriate for late stages

45
Q

adaptive trial deisgn

A

I - SPY
- umbrella trial: many agents tested in parallel with placebo
- basket: patients grouped by genotype and other disease features
+ : compare effects on biomarkers, adaptive dosed, shared placebo and trial, continuous comparison
-: hard to assess effects, treatment baskets harder to determine, no established intermediate endpoints

Psych 403 (10 decks)

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