The PART THE CLOUD (PTC) Bioenergetics/ Mitochondria, Clearance Related, Vascular Contributions and Inflammation Clinical Trials Program will accelerate the testing of innovative therapy, including experimental or repurposed drug and/or experimental or repurposed device in the earliest stages of neurodegeneration. For this program, therapeutic approaches to Alzheimer’s disease (AD) and related dementias (ADRD) should have a focus on biological mechanisms related to vascular pathology, mitochondrial/ bioenergetics, clearance related mechanisms (autophagy, lysosomal and lymphatic/ glymphatic systems) and inflammation. Projects will be considered that move experimental or repurposed drug candidates and/or experimental or repurposed trial ready devices into Phase 1 or Phase 2 clinical trials for AD and/or ADRD.
PTC aims to accelerate the translation of possible therapeutics in the clinical setting. PTC will promote human studies to advance innovative ideas for early phase human trials (Phase 1 or Phase 2) that address therapies (an experimental or repurposed drug and/or experimental or repurposed device) to address vascular pathology, mitochondrial/ bioenergetics, clearance-related mechanisms (autophagy, lysosomal and lymphatic/ glymphatic systems) and inflammation.
PTC will fund best-in-class projects that effectively demonstrate a proposal to translate an experimental or repurposed drug and/or experimental or repurposed device into human clinical trials. The goal of PTC is to advance promising ideas that have promise of stopping or slowing the progression of neurodegenerative disease.
Both not-for-profit and for-profit agencies from the international scientific community are eligible. Small for-profit agencies must submit documentation of net assets and annual earnings for consideration during the letter of intent process. Not-for-profit organizations must submit documentation verifying status during the letter of intent process. Collaborations between not-for-profit and for-profit organizations are strongly encouraged. Researchers with full-time staff or faculty appointments are encouraged to apply. Applications from post-doctoral candidates will not be accepted. For questions as to whether an investigator or organization is eligible, please contact the Alzheimer’s Association at email@example.com.
Submitting a Letter of Intent
The Letter of Intent (LOI) is a required step in the application process. LOIs must be completed online at https://proposalcentral.com. First-time users must register and complete a Professional Profile to begin the application process. No hard copies will be accepted.
LOI review and evaluation
All LOIs will be evaluated prior to invitation to submit a full application. The Alzheimer’s Association and a select panel of experts will review LOIs for relevance to the RFA and goals of the RFA. Applicants will need to provide the area of therapeutic target (i.e., Bioenergetics/ Mitochondria, Clearance Related, Vascular Contributions and Inflammation) and will need to identify if experimental/ repurposed drug or device. Only LOIs that meet program specific guidelines as outlined in this request for applications will be invited to submit full applications. Feedback is not provided for LOIs that are not invited to submit a full application.
Submitting a full application
For those invited to submit a full application, additional materials will be required. Templates and instructions will be provided after LOI approval.
The full grant application consists of the following:
- Problem statement – 1 page
- Work plan – 5 pages
- Available resources and budget justification – 2 pages
- Milestones (no upload required; completed online)
- The budget must be broken down into six-month increments, with key milestones listed for each six-month budget period.
- Milestones should align with your overall project goals and be designed such that it can be clearly determined if each one has been met.
- For each milestone, indicate the relevant project aim of which it is a part of.
- Next to each project aim, include the amount of budget allocated to that aim.
- Gantt chart of proposed study (including go/no-go decision steps) – 1 page
- Therapeutic rationale – 1 page
- Biosketch or curriculum vitae (PI/Co-PI) – 4 pages each for PI and other key personnel
- Plan for data sharing – 1 page
The full grant application will be reviewed by a panel of experts on both scientific and trial design with special attention to:
- Rationale of the target being pursued.
- Quality of the proposed trial design, including participant selection criteria and trial methodology.
- Applicant information.
- Quality and adequacy of the available resources and budget.
Deadlines and award timeline
Letter of Intent: Open now at https://proposalcentral.com
LOI deadline: January 6, 2020
Application invitations sent: Week of January 27, 2020
Application deadline: March 2, 2020
Award notifications: By April 30, 2020
For more information, contact firstname.lastname@example.org or view the full RFA.